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# Data Set Core Medata Schema 2.16.840.1.113883.3.1937.777.64.1.2

Name | Id
--- | ---
Core Medata Schema (3.0) | 2.16.840.1.113883.3.1937.777.64.1.2
Version / effective date | Expiration date
2022‑11‑28 |
Description
NFDI4Health General Metadataschema V3
Name | Details [‑] |
--- | --- | ---
Resource | link
Id | (2022‑11‑28)
Description | Resource
### Properties
No 3_0 | 1
Rationale | Description: Group of items providing Information about a resource. Resources can be, for example, files or parts of them (e.g. datasets or study documents such as study protocols or questionnaires) or also abstractions (e.g. studies or substudies/data collection events).
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): no
Used by | one transaction, 0 templates, inherited 0 times
| This concept is used in transaction Create NFDI4Health Resource (1 … 1 Mandatory) in scenario Researcher Scenario
identifier |
Id | (2022‑11‑28)
Synonym | resource_identifier
Description | ID of the [Resource]
### Properties
No 3_0 | 1.1
Rationale | Description: Unique identifier of the resource used for identification within the NFDI4Health. Additional information: The identifier is assigned automatically.
Source | NFDI4Health DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): yes
Value Domain | String
Used by | one transaction, 0 templates, inherited once
| This concept is used in transaction Create NFDI4Health Resource (1 … 1 Mandatory) in scenario Researcher Scenario This concept is inherited by concept identifier in dataset Module Design (V3.3) (v3.3)
classification | link
Id | (2022‑11‑28)
Synonym | resource_classification
Description | Classification of the resource within the predefined categories
### Properties
No 3_0 | 1.2
Rationale | Description: Group of items providing Information about classification of the resource within the predefined categories.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Used by | one transaction, 0 templates, inherited once
| This concept is used in transaction Create NFDI4Health Resource (1 … 1 Required) in scenario Researcher Scenario This concept is inherited by concept classification in dataset Module Design (V3.3) (v3.3)
resourceType |
Id | (2022‑11‑28)
Synonym | resource_type
Description | Type of the resource
### Properties
No 3_0 | 1.2.1
Rationale | Description: A term describing the resource. Additional information: The selected value determines which type of information needs to be provided.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: You can register a study, a study protocoll, a questionnaire, etc.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Study | A detailed examination, analysis, or critical inspection of a subject designed to discover facts about it [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C0947630" (Scientific Study (Research Activity)) from code system "Unified Medical Language System"
Substudy/Data collection event | A part of a study [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C4288169" (Substudy Details (Intellectual Product)) from code system "Unified Medical Language System"
Dataset | Data encoded in a defined structure [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C0150098" (Data Set (Intellectual Product)) from code system "Unified Medical Language System"
Study protocol | The formal plan of an experiment or research activity, including the objective, rationale, design, materials and methods for the conduct of the study; intervention description, and method of data analysis [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C2985594" (Study Protocol Document (Intellectual Product)) from code system "Unified Medical Language System"
Protocol amendment | A written description of a change(s) to, or formal clarification of, a protocol [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C4321383" (Protocol Amendment (Intellectual Product)) from code system "Unified Medical Language System"
Data dictionary | A document describing the data, including metadata, and their meaning, usage, and relationship to other data [NFDI4Health]. | code "009" (Data dictionary) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Informed consent form | A template of a document explaining all the relevant information to assist an individual in understanding the expectations and risks in making a decision about a procedure. This document is presented to and signed by the individual or guardian [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C0009797" (Consent Forms (Intellectual Product)) from code system "Unified Medical Language System"
Patient information sheet | (1) A document that informs the patient about procedures, potential risks or side effects of a proposed medication or operation; (2) A document that informs the patient about data being collected [NFDI4Health]. | code "C5552264" (Resource information for patient (Intellectual Product)) from code system "Unified Medical Language System"
Manual of operations (SOPs) | Detailed, written instructions to achieve uniformity of the performance of a specific function [EMA (European Medicines Agency - ICH: E 6 (R2): Guideline for good clinical practice - Step 5 (europa.eu))]. | code "C3889288" (Standard Operating Procedure List (Intellectual Product)) from code system "Unified Medical Language System"
Statistical analysis plan | A document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C3889277" (Statistical Analysis Plan (Intellectual Product)) from code system "Unified Medical Language System"
Data management plan | A document that addresses the overall data management process [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health]. | code "C3899449" (Data Management Plan (Intellectual Product)) from code system "Unified Medical Language System"
Case report form | A printed, optical, or electronic document designed to record all of the clinical study-required information stipulated in the protocol to be reported to the sponsor on each clinical trial subject [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C1516308" (Case Report Form (Intellectual Product)) from code system "Unified Medical Language System"
Code book | Pre-defined categorization scheme used for content coding, a data collection technique to transform qualitative data (textual, video, audio or still-image) originally produced for other purposes into quantitative data [DDI (https://ddialliance.org/Specification/DDI-CV/TypeOfInstrument_1.1.html)]. | code "011" (Codebook) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Questionnaire | Set of pre-determined questions presented to study participants [DDI (https://ddialliance.org/Specification/DDI-CV/TypeOfInstrument_1.1.html)]. | code "C0034394" (Questionnaires (Intellectual Product)) from code system "Unified Medical Language System"
Interview scheme and themes | Themes, topics, and/or questions used in an interview. Can vary between loosely defined themes to more exactly formulated questions. There is more flexibility than in an unstructured questionnaire regarding which questions are asked of each participant and how they are conveyed [DDI (https://ddialliance.org/Specification/DDI-CV/TypeOfInstrument_1.1.html)]. | code "016" (Interview schema and themes) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Observation guide | Guidelines (i.e., directions or instructions regarding the methods and procedures to be used for collecting the data) regarding what will be observed. Depending on the study design, an observation guide can be more or less structured, ranging from exact specifications and scales to loosely formulated ideas [DDI (https://ddialliance.org/Specification/DDI-CV/TypeOfInstrument_1.1.html)]. | code "017" (Observation guide) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Discussion guide | Guidelines (i.e., directions or instructions regarding the methods and procedures to be used for collecting the data) for a group discussion. Depending on the study design, a discussion guide can be more or less structured, ranging from exactly formulated questions to general ideas on what to discuss. For example, a list of topics to be discussed in a focus group, or themes formulated by a researcher to direct a blog discussion, etc. [DDI (https://ddialliance.org/Specification/DDI-CV/TypeOfInstrument_1.1.html)]. | code "018" (Discussion guide) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Participant tasks | A description of tasks that participants are asked to carry out as a part of the data collection process. For example, marking places on a map, taking photographs, telling a fairy tale, etc. [DDI (https://ddialliance.org/Specification/DDI-CV/TypeOfInstrument_1.1.html)]. | code "019" (Participant tasks) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other data collection instrument | A data collection instrument that is not covered by any of the other values in this list [NFDI4Health]. | code "020" (Other data collection instrument) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other study document | A study document that is not covered by any of the other values in this list [NFDI4Health]. | code "021" (Other study document) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other | A resource that is not covered by any of the other values in this list [NFDI4Health, DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C020539" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Resource_Type_UMLS_Local (version 2022‑06‑16 14:33:55)
Used by | one transaction, 0 templates, inherited once
| This concept is used in transaction Create NFDI4Health Resource (1 … 1 Mandatory) in scenario Researcher Scenario This concept is inherited by concept resourceType in dataset Module Design (V3.3) (v3.3)
resourceTypeGeneral |
Id | (2022‑11‑28)
Synonym | resource_type_general
Description | A more general type of the resource
### Properties
No 3_0 | 1.2.2
Rationale | Description: A more general term describing the resource which forms a pair with the property "Type of the resource" (e.g. "Questionnaire"/"Text").
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 1..1, if resource_type != ("Study" OR "Substudy/Data collection event" OR "Dataset")
Comment | Display information? (Data capturing): yes Display information? (Data visualization): no
Operationalization | Short input help: You can select "Text" for most of the study documents, e.g. for questionnaires, informed consent forms, case report forms, etc.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Audiovisual | A series of visual representations imparting an impression of motion when shown in succession. May or may not include sound. For example, films, video, etc. [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C19695" (Audiovisual Material (Manufactured Object)) from code system "NCI Metathesaurus"
Book | A medium for recording information in the form of writing or images, typically composed of many pages bound together and protected by a cover [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C16360" (Book (Manufactured Object)) from code system "NCI Metathesaurus"
Book chapter | One of the main divisions of a book [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C0005990" (Book Chapter (Intellectual Product)) from code system "Unified Medical Language System"
Collection | An aggregation of resources, which may encompass collections of one Resource Type as well as those of mixed types. A collection is described as a group; its parts may also be separately described. For example, a collection of samples, or various files making up a report [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C45261" (Item Collection (Idea or Concept)) from code system "NCI Metathesaurus"
Computational notebook | A virtual notebook environment used for literate programming [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "051" (Computational Notebook) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Conference paper | Article that is written with the goal of being accepted to a conference [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C0814814" (Conference Paper (Intellectual Product)) from code system "Unified Medical Language System"
Conference proceeding | Collection of academic papers published in the context of an academic conference [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C0009664" (Conference Proceedings as Topic (Intellectual Product)) from code system "Unified Medical Language System"
Data paper | A factual and objective publication with a focused intent to identify and describe specific data, sets of data, or data collections to facilitate discoverability [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "052" (Data Paper) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Dataset | Data encoded in a defined structure [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C47824" (Data Set (Idea or Concept)) from code system "NCI Metathesaurus"
Dissertation | A written essay, treatise, or thesis, especially one written by a candidate for the degree of Doctor of Philosophy [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C0376645" (Academic Dissertation (Intellectual Product)) from code system "Unified Medical Language System"
Event | A non-persistent, time-based occurrence [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C25499" (Event (Event)) from code system "NCI Metathesaurus"
Image | A visual representation other than text. For example, digitised or born digital images, drawings or photographs [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C48179" (Image (Entity)) from code system "NCI Metathesaurus"
Interactive resource | A resource requiring interaction from the user to be understood, executed, or experienced. For example, training modules, files that require use of a viewer (e.g., Flash), or query/response portals [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "053" (Interactive Resource) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Journal | A scholarly publication consisting of articles that is published regularly throughout the year [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C40976" (Journal (Intellectual Product)) from code system "NCI Metathesaurus"
Journal article | A written composition on a topic of interest, which forms a separate part of a journal [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C0282420" (Journal Article (Intellectual Product)) from code system "Unified Medical Language System"
Model | An abstract, conceptual, graphical, mathematical or visualization model that represents empirical objects, phenomena, or physical processes [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C16866" (Model (Intellectual Product)) from code system "NCI Metathesaurus"
Output management plan | A formal document that outlines how research outputs are to be handled both during a research project and after the project is completed. For example, data management plan [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "054" (Output Management Plan) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Peer review | Evaluation of scientific, academic, or professional work by others working in the same field [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C16963" (Peer Review (Occupational Activity)) from code system "NCI Metathesaurus"
Physical object | An inanimate, three dimensional object or substance. For example, artifacts, specimens [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C0347997" (Physical object) from code system "Unified Medical Language System"
Preprint | A version of a scholarly or scientific paper that precedes formal peer review and publication in a peer-reviewed scholarly or scientific journal [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C4704708" (Preprint) from code system "Unified Medical Language System"
Report | A document that presents information in an organized format for a specific audience and purpose [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C25375" (Report (Intellectual Product)) from code system "NCI Metathesaurus"
Service | An organized system of apparatus, appliances, staff, etc., for supplying some function(s) required by end users. For example, data management service, or long-term preservation service [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C47920" (Service (Activity)) from code system "NCI Metathesaurus"
Software | A computer program other than a computational notebook, in either source code (text) or compiled form. Use this type for general software components supporting scholarly research. Use the “Computational Notebook” value for virtual notebooks [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C17146" (Computer Program (Intellectual Product)) from code system "NCI Metathesaurus"
Sound | A resource primarily intended to be heard. For example, audio recording [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C64383" (Sound (Natural Phenomenon or Process)) from code system "NCI Metathesaurus"
Standard | Something established by authority, custom, or general consent as a model, example, or point of reference [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C81893" (Standard (Intellectual Product)) from code system "NCI Metathesaurus"
Text | A resource consisting primarily of words for reading that is not covered by any other textual resource type in this list [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C25704" (Text (Manufactured Object)) from code system "NCI Metathesaurus"
Workflow | A structured series of steps which can be executed to produce a final outcome, allowing users a means to specify and enact their work in a more reproducible manner [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C42753" (Workflow (Conceptual Entity)) from code system "NCI Metathesaurus"
Other | A resource that is not covered by any of the other values in this list [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C17649" (Other (Qualitative Concept)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Resource_Type_General_NCI_UMLS_Local (version 2022‑06‑27 14:09:14)
Used by | one transaction, 0 templates, inherited once
| This concept is used in transaction Create NFDI4Health Resource (0 … 1 Conditional) in scenario Researcher Scenario This concept is inherited by concept resourceTypeGeneral in dataset Module Design (V3.3) (v3.3)
titles | link
Id | (2022‑11‑28)
Synonym | resource_titles
Description | Title(s)/name(s) of the [RESOURCE]
### Properties
No 3_0 | 1.3
Rationale | Description: Group of items providing Information about title(s)/name(s) of the resource.
Source | NFDI4Health
Comment | Cardinality: 1..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept titles in dataset Module Design (V3.3) (v3.3)
text |
Id | (2022‑11‑28)
Synonym | text
Description | Title/name
### Properties
No 3_0 | 1.3.1
Rationale | Description: Scientific unabbreviated title or name of the resource. Additional information: If no official title/name has been defined yet, please provide a title/name that is suitable for public display.
Source | NFDI4Health DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Please provide at least one title/name of the resource. If the original title is not in English, please also provide an English translation of the original title.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept text in dataset Module Design (V3.3) (v3.3)
language |
Id | (2022‑11‑28)
Synonym | language
Description | Language of the title/name
### Properties
No 3_0 | 1.3.2
Rationale | Description: Language of the title/name.
Source | NFDI4Health DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
EN (English) |  | code "C0376245" (English Language) from code system "Unified Medical Language System"
DE (German) |  | code "C0017477" (German language) from code system "Unified Medical Language System"
ES (Spanish) |  | code "C0037750" (Spanish Language) from code system "Unified Medical Language System"
FR (French) |  | code "C0376246" (French language) from code system "Unified Medical Language System"
Other |  | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Language_UMLS (version 2022‑06‑27 22:43:37)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept language in dataset Module Design (V3.3) (v3.3)
acronyms | link
Id | (2022‑11‑28)
Synonym | resource_acronyms
Description | Acronym(s) of the [RESOURCE]
### Properties
No 3_0 | 1.4
Rationale | Description: Group of items providing Information about acronym(s) of the resource.
Source | NFDI4Health
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): no
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept acronyms in dataset Module Design (V3.3) (v3.3)
text |
Id | (2022‑11‑28)
Synonym | text
Description | Acronym
### Properties
No 3_0 | 1.4.1
Rationale | Description: If existing, acronym(s) of the resource.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: The property refers primarily to studies which often have an acronym. For other types of resources, a short title (preferably up to 5 words) can be provided, e.g. "NAKO-COVID Questionnaire".
Value Domain | String
Example | NAKO
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept text in dataset Module Design (V3.3) (v3.3)
language |
Id | (2022‑11‑28)
Synonym | language
Description | Language of the acronym
### Properties
No 3_0 | 1.4.2
Rationale | Description: Language of the acronym.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
EN (English) |  | code "C0376245" (English Language) from code system "Unified Medical Language System"
DE (German) |  | code "C0017477" (German language) from code system "Unified Medical Language System"
ES (Spanish) |  | code "C0037750" (Spanish Language) from code system "Unified Medical Language System"
FR (French) |  | code "C0376246" (French language) from code system "Unified Medical Language System"
Other |  | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Language_UMLS (version 2022‑06‑27 22:43:37)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept language in dataset Module Design (V3.3) (v3.3)
descriptionEnglish | link
Id | (2022‑11‑28)
Synonym | resource_description_english
Description | English description of the [RESOURCE]
### Properties
No 3_0 | 1.5
Rationale | Description: Group of items with an English description of the resource.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept descriptionEnglish in dataset Module Design (V3.3) (v3.3)
text |
Id | (2022‑11‑28)
Synonym | text
Description | English description of the [RESOURCE]
### Properties
No 3_0 | 1.5.1
Rationale | Description: A short plain text summary describing the resource in English. Additional information: An English description is mandatory to facilitate the search.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: The provided information should be understandable by scientific audience.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept text in dataset Module Design (V3.3) (v3.3)
language |
Id | (2022‑11‑28)
Synonym | language
Description | Language of the description
### Properties
No 3_0 | 1.5.2
Rationale | Description: Language of the description text. Additional information: English is a default value.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Terminology Asscociation | This concept is represented by code "C0376245" (English Language) from code system 2.16.840.1.113883.6.86 Unified Medical Language System)
Value Domain | Code
Choice list |
Concept List
Concept | Description
EN (English) |
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept language in dataset Module Design (V3.3) (v3.3)
descriptionNonEnglish | link
Id | (2022‑11‑28)
Synonym | resource_descriptions_non_english
Description | Additional description(s) of the [RESOURCE]
### Properties
No 3_0 | 1.6
Rationale | Description: Group of items with description(s) of the resource written not in English.
Source | NFDI4Health
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited 2 times
| This concept is inherited by concept descriptionNonEnglish in dataset Core Metadata Schema (V3.3) This concept is inherited by concept descriptionNonEnglish in dataset Module Design (V3.3) (v3.3)
text |
Id | (2022‑11‑28)
Synonym | text
Description | Description
### Properties
No 3_0 | 1.6.1
Rationale | Description: Short plain text summary of the resource other than in English.
Source | NFDI4Health DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Additional descriptions of the resource are optional. The provided information should be understandable by scientific audience.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited 2 times
| This concept is inherited by concept text in dataset Core Metadata Schema (V3.3) This concept is inherited by concept text in dataset Module Design (V3.3) (v3.3)
language |
Id | (2022‑11‑28)
Synonym | language
Description | Language of the description
### Properties
No 3_0 | 1.6.2
Rationale | Description: Language of the description text.
Source | NFDI4Health DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
DE (German) |  | code "C0017477" (German language) from code system "Unified Medical Language System"
ES (Spanish) |  | code "C0037750" (Spanish Language) from code system "Unified Medical Language System"
FR (French) |  | code "C0376246" (French language) from code system "Unified Medical Language System"
Other |  | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Language_NonEnglish_UMLS (version 2023‑10‑09 12:15:14)
Used by | 0 transactions, 0 templates, inherited 2 times
| This concept is inherited by concept language in dataset Core Metadata Schema (V3.3) This concept is inherited by concept language in dataset Module Design (V3.3) (v3.3)
keywords | link
Id | (2022‑11‑28)
Synonym | resource_keywords
Description | Keyword(s) describing the [RESOURCE]
### Properties
No 3_0 | 1.7
Rationale | Description: Group of items providing Information about keywords describing the resource. Additional information: The findability of the resource can be significantly increased if proper keywords are stated.
Source | NFDI4Health
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept keywords in dataset Module Design (V3.3) (v3.3)
label |
Id | (2022‑11‑28)
Synonym | resource_keywords_label
Description | Keyword
### Properties
No 3_0 | 1.7.1
Rationale | Description: Keyword(s) describing the resource. Additional information: The use of terms from established classifications/vocabularies (e.g. MeSH, UMLS, SNOMED CT) is preferred. However, also self-assigned keywords are allowed.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Preferably, use terms from MeSH (https://meshb.nlm.nih.gov/search) or UMLS (https://uts.nlm.nih.gov/uts/umls/home).
Value Domain | String
Example | SARS-CoV-2
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept label in dataset Module Design (V3.3) (v3.3)
code |
Id | (2022‑11‑28)
Synonym | resource_keywords_label_code
Description | Code of the keyword
### Properties
No 3_0 | 1.7.2
Rationale | Description: If known, the code of the keyword in a classification/vocabulary.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): no
Operationalization | Short input help: If found, the code from the classification/vocabulary used.
Value Domain | String
Example | http://id.nlm.nih.gov/mesh/D000086402
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept code in dataset Module Design (V3.3) (v3.3)
languages |
Id | (2022‑11‑28)
Synonym | resource_languages
Description | Language(s) of the [RESOURCE]
### Properties
No 3_0 | 1.8
Rationale | Description: Language(s) in which a study/substudy is conducted, or a language in which a study document is composed.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description
Language names from the ISO 639-1 list |
Value Set required ISO 639-1 (version 2023‑10‑09 12:24:30)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept languages in dataset Module Design (V3.3) (v3.3)
webpage |
Id | (2022‑11‑28)
Synonym | resource_web_page
Description | Web page of the [RESOURCE]
### Properties
No 3_0 | 1.9
Rationale | Description: If existing, a link to the web page directly relevant to the resource. Additional information: Other web pages related to the resource can additionally be entered in the section "Related resources".
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept webpage in dataset Module Design (V3.3) (v3.3)
nonStudyDetails | link
Id | (2022‑11‑28)
Synonym | resource_non_study_details
Description | Detailed information about the [RESOURCE]
### Properties
No 3_0 | 1.10
Rationale | Description: Group of items applicable only to the resources which are not a study/substudy.
Source | NFDI4Health
Comment | Cardinality: 1..1, if resource_type != ("Study" OR "Substudy/Data collection event"); otherwise 0..0
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept nonStudyDetails in dataset Module Design (V3.3) (v3.3)
version |
Id | (2022‑11‑28)
Synonym | resource_version
Description | Version of the [RESOURCE]
### Properties
No 3_0 | 1.10.1
Rationale | Description: If existing, the version number of the resource.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept version in dataset Module Design (V3.3) (v3.3)
format |
Id | (2022‑11‑28)
Synonym | resource_format
Description | Format of the [RESOURCE]
### Properties
No 3_0 | 1.10.2
Rationale | Description: Technical format of the resource.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: E.g., XML, PDF, XLSX, etc.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept format in dataset Module Design (V3.3) (v3.3)
useRights | link
Id | (2022‑11‑28)
Synonym | resource_use_rights
Description | Information about the rights to (re-)use the [RESOURCE]
### Properties
No 3_0 | 1.10.3
Rationale | Description: Group of items providing Information about the rights to (re-)use the resource.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept useRights in dataset Module Design (V3.3) (v3.3)
label |
Id | (2022‑11‑28)
Synonym | resource_use_rights_label
Description | License
### Properties
No 3_0 | 1.10.3.1
Rationale | Description: License defining the rights to (re-)use the resource.
Source | NFDI4Health DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select one value from the list. If “Other” is selected, an explanation of the (re-)use terms and conditions can be provided in the property “Additional information about use rights”.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
CC0 1.0 (Creative Commons Zero v1.0 Universal) | This license allows re-users to distribute, remix, adapt, and build upon the material in any medium or format, with no conditions. It is a public dedication tool, which allows creators to give up their copyright and put their works into the worldwide public domain. For more details, visit https://creativecommons.org/publicdomain/zero/1.0/ [Creative Commons (https://creativecommons.org/about/cclicenses/)]. | code "CC0-1.0 " (Creative Commons Zero v1.0 Universal) from code system "SPDXLicense"
CC BY 4.0 (Creative Commons Attribution 4.0 International) | This license allows re-users to distribute, remix, adapt, and build upon the material in any medium or format, so long as attribution is given to the creator. The license allows for commercial use. For more details, visit https://creativecommons.org/licenses/by/4.0/ [Creative Commons (https://creativecommons.org/about/cclicenses/)]. | code "CC-BY-4.0 " (Creative Commons Attribution 4.0 International) from code system "SPDXLicense"
CC BY-NC 4.0 (Creative Commons Attribution Non Commercial 4.0 International) | This license allows re-users to distribute, remix, adapt, and build upon the material in any medium or format for non-commercial purposes only, and only so long as attribution is given to the creator. For more details, visit https://creativecommons.org/licenses/by-nc/4.0/ [Creative Commons (https://creativecommons.org/about/cclicenses/)]. | code "CC-BY-NC-4.0 " (Creative Commons Attribution Non Commercial 4.0 International) from code system "SPDXLicense"
CC BY-SA 4.0 (Creative Commons Attribution Share Alike 4.0 International) | The license allows re-users to distribute, remix, adapt, and build upon the material in any medium or format, so long as attribution is given to the creator. The license allows for commercial use. If you remix, adapt, or build upon the material, you must license the modified material under identical terms. For more details, visit https://creativecommons.org/licenses/by-sa/4.0/ [Creative Commons (https://creativecommons.org/about/cclicenses/)]. | code "CC-BY-SA-4.0 " (Creative Commons Attribution Share Alike 4.0 International) from code system "SPDXLicense"
CC BY-NC-SA 4.0 (Creative Commons Attribution Non Commercial Share Alike 4.0 International) | The license allows re-users to distribute, remix, adapt, and build upon the material in any medium or format for non-commercial purposes only, and only so long as attribution is given to the creator. If you remix, adapt, or build upon the material, you must license the modified material under identical terms. For more details, visit https://creativecommons.org/licenses/by-nc-sa/4.0/ [Creative Commons (https://creativecommons.org/about/cclicenses/)]. | code "CC-BY-NC-SA-4.0 " (Creative Commons Attribution Non Commercial Share Alike 4.0 International) from code system "SPDXLicense"
All rights reserved | Indication that the copyright holder reserves, or holds for its own use, all the rights provided by copyright law. It is not allowed to re-use the resource [NFDI4Health]. | code "013" (All rights reserved) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other | A license that is not covered by any of the other values in this list [NFDI4Health]. | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Not applicable | The license is not applicable for the resource [NFDI4Health]. | code "C1272460" (Not Applicable (Qualitative Concept)) from code system "Unified Medical Language System"
Unknown | It is unknown whether there is a license defining the use rights of the resource [NFDI4Health]. | code "C0439673" (Unknown (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Use_Rights_Label_SPDX_UMLS_Local (version 2023‑08‑31 14:59:57)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept label in dataset Module Design (V3.3) (v3.3)
confirmations | link
Id | (2022‑11‑28)
Synonym | resource_use_rights_confirmations
Description | Important nformation about licensing, if a Creative Commons liesense is selected.
### Properties
No 3_0 | 1.10.3.2
Rationale | Description: Group of items applicable if a Creative Commons liesense is selected.
Source | NFDI4Health
Comment | Cardinality: 1..1, if resource_use_rights_label != ("CC0 1.0 (Creative Commons Zero v1.0 Universal)" OR "All rights reserved" OR "Other" OR "Not applicable"); otherwise 0..0
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept confirmations in dataset Module Design (V3.3) (v3.3)
authority |
Id | (2022‑11‑28)
Synonym | resource_use_rights_confirmation_authority
Description | Do you confirm that the authors have authority to license the [RESOURCE]?
### Properties
No 3_0 | 1.10.3.2.1
Rationale | Description: Confirmation that the authors have authority to license the resource.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): no
Value Domain | Boolean
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept authority in dataset Module Design (V3.3) (v3.3)
terms |
Id | (2022‑11‑28)
Synonym | resource_use_rights_confirmation_terms
Description | Do you confirm that the authors have read and understood the terms of the chosen license?
### Properties
No 3_0 | 1.10.3.2.2
Rationale | Description: Confirmation that the authors have read and understand the terms of the chosen license.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): no
Value Domain | Boolean
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept terms in dataset Module Design (V3.3) (v3.3)
irrevocability |
Id | (2022‑11‑28)
Synonym | resource_use_rights_confirmation_irrevocability
Description | Do you confirm that the authors understand that Creative Commons (CC) licensing is irrevocable?
### Properties
No 3_0 | 1.10.3.2.3
Rationale | Description: Confirmation that the authors understand that Creative Commons (CC) licensing is not revocable. Additional information: The resource can be licensed using a CC-license only if it is free of the third-party rights.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): no
Value Domain | Boolean
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept irrevocability in dataset Module Design (V3.3) (v3.3)
supportByLicencing |
Id | (2022‑11‑28)
Synonym | resource_use_rights_support_by_licencing
Description | Do you confirm that the authors allow NFDI4Health to license the document?
### Properties
No 3_0 | 1.10.3.2.4
Rationale | Description: Confirmation that NFDI4Health is allowed to licence the document, i.e. to mark the resource with the licence information.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): no
Value Domain | Boolean
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept supportByLicencing in dataset Module Design (V3.3) (v3.3)
description |
Id | (2022‑11‑28)
Synonym | resource_use_rights_description
Description | Additional information about use rights
### Properties
No 3_0 | 1.10.3.3
Rationale | Description: Any additional descriptive information explaining terms and conditions to (re-)use the resource.
Source | NFDI4Health DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: If “Other” is selected in the property "License", the preferred license or terms and conditions for (re-)use can be specified here.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept description in dataset Module Design (V3.3) (v3.3)
roles | link
Id | (2022‑11‑28)
Synonym | roles
Description | Roles
### Properties
No 3_0 | 1.11
Rationale | Description: Group of items providing information about person(s), group(s) of persons or institution(s)/organisation(s) contributing to the resource. Additional information: For each resource, there may be multiple roles, but at least one person, group of persons or institution/organisation must be specified.
Source | NFDI4Health
Comment | Cardinality: 1..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept roles in dataset Module Design (V3.3) (v3.3)
nameType |
Id | (2022‑11‑28)
Synonym | role_name_type
Description | Type of the name
### Properties
No 3_0 | 1.11.1
Rationale | Description: Personal or organisational/group type of the name.
Source | NFDI4Health DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): no
Operationalization | Short input help: Personal or organisational/group name?
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Personal | Type of the name which can be used to denote a person [NFDI4Health]. | code "C1519021" (Personal Attribute ) from code system "Unified Medical Language System"
Organisational | Type of the name which can be used to denote a group of persons or an institution/organisation [NFDI4Health]. | code "C0220885" (Organizational (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Role_Name_Type_UMLS (version 2022‑07‑05 17:37:36)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept nameType in dataset Module Design (V3.3) (v3.3)
organisational | link
Id | (2022‑11‑28)
Synonym | role_name_organisational_group
Description | Details about the organisation/institution/group/etc.
### Properties
No 3_0 | 1.11.2
Rationale | Description: Group of items providing information about group(s) of persons, institution(s) or organisation(s) contributing to the resource. Additional information: Group of items applicable to organisational/group names.
Source | NFDI4Health
Comment | Cardinality: 1..1, if role_name_type == "Organisational"; otherwise 0..0
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Operationalization | Short input help: Organisational name can be used to denote a research group or an institution.
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept organisational in dataset Module Design (V3.3) (v3.3)
type |
Id | (2022‑11‑28)
Synonym | role_name_organisational_group_type
Description | Type of the role
### Properties
No 3_0 | 1.11.2.1
Rationale | Description: Type of the role an organisation, institution or group fulllfils. For example, this can be a sponsor of the study or a group of authors of the document.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Which role does the organisation/institution/group/etc. fulllfil? Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Contact | (1) An entity with knowledge of how to access, troubleshoot, or otherwise field issues related to the resource ; (2) An entity acting as a channel for communication between groups or on behalf of a group [DataCite (https://doi.org/10.14454/3w3z-sa82), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health]. | code "C25461" (Contact Person (Human)) from code system "NCI Metathesaurus"
Creator/Author | (1) An authoritative body who brought the item into existence; (2) A group of main researchers or an organisation involved in producing the data; (3) A collective name of the authors of the resource [DataCite (https://doi.org/10.14454/3w3z-sa82), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health]. | code "C42781" (Author (Human)) from code system "NCI Metathesaurus"
Funder (public) | An organization that supports (sponsors) something through some kind of financial contribution [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "046" (Public Funder) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Funder (private) | A private organization that supports (sponsors) something through some kind of financial contribution [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "047" (Private Funder) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Sponsor (primary) | (1) An organization taking responsibility for and initiating a study; (2) An individual, organization, group or other legal person taking responsibility for securing the arrangements to initiate and/or manage a study (including arrangements to ensure that the study design meets appropriate standards and to ensure appropriate conduct and reporting). In commercial trials, the primary sponsor is normally the main applicant for regulatory authorization to begin the study. It may or may not be the main funder [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "037" (Primary Sponsor) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Sponsor (secondary) | An organization who has agreed with the primary sponsor to take responsibility for a study [WHO (https://www.who.int/clinical-trials-registry-platform/unambiguous-trial-identification/the-universal-trial-number-(utn)), NFDI4Health]. | code "C142679" (Secondary Sponsor (Human)) from code system "NCI Metathesaurus"
Sponsor-Investigator | An organization both initiating and conducting the study [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C142695" (Sponsor-Investigator (Professional or Occupational Group)) from code system "NCI Metathesaurus"
Research group | Typically refers to a group of individuals with a lab, department, or division that has a specifically defined focus of activity [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "048" (Research Group) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Data collector | Person/institution responsible for finding or gathering/collecting data under the guidelines of the author(s) or Principal Investigator (PI) [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "038" (Data Collector) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Data curator | Person tasked with reviewing, enhancing, cleaning, or standardizing metadata and the associated data submitted for storage, use, and maintenance within a data centre or repository [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "039" (Data Curator) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Data manager | Person (or organisation with a staff of data managers, such as a data centre) responsible for maintaining the finished resource [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C51820" (Data Manager (Professional or Occupational Group)) from code system "NCI Metathesaurus"
Distributor | Institution tasked with responsibility to generate/disseminate copies of the resource in either electronic or print form [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C48289" (Distributor (Human)) from code system "NCI Metathesaurus"
Hosting institution | Typically, the organisation allowing the resource to be available on the internet through the provision of its hardware/software/operating support [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "049" (Hosting Institution) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Producer | Typically, a person or organisation responsible for the artistry and form of a media product [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C45336" (Producer (Human)) from code system "NCI Metathesaurus"
Publisher | Entity that holds, archives, publishes prints, distributes, releases, issues, or produces the resource [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C43416" (Publisher (Occupation or Discipline)) from code system "NCI Metathesaurus"
Registration agency | Institution/organisation officially appointed by a Registration Authority to handle specific tasks within a defined area of responsibility [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "050" (Registration Agency) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Registration authority | A standards-setting body from which Registration Agencies obtain official recognition and guidance [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C74932" (Registration Authority (Organization)) from code system "NCI Metathesaurus"
Rights holder | Person or institution owning or managing property rights, including intellectual property rights over the resource [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "044" (Rights Holder) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Supervisor | Designated administrator over one or more groups/teams working to produce a resource, or over one or more steps of a development process [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C134832" (Supervisor (Professional or Occupational Group)) from code system "NCI Metathesaurus"
Other | Any institution or group of individuals making a significant contribution to the development and/or maintenance of the resource, but whose contribution is not adequately described by any of the other values for “Role type” [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C17649" (Other (Qualitative Concept)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Organisational_Roles_NCI_Local (version 2023‑08‑23 21:03:03)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept type in dataset Module Design (V3.3) (v3.3)
fundingId |
Id | (2022‑11‑28)
Synonym | role_name_organisational_group_type_funding_id
Description | Funding identifier
### Properties
No 3_0 | 1.11.2.2
Rationale | Description: Identifier assigned by a funder to the resource.
Source | NFDI4Health DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..*, if role_name_organisational_group_type == ("Funder (public)" OR "Funder (private)"); otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: If available, you can enter a funding identifier
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept fundingId in dataset Module Design (V3.3) (v3.3)
name |
Id | (2022‑11‑28)
Synonym | role_name_organisational_group_name
Description | Name of the organisation/institution/group
### Properties
No 3_0 | 1.11.2.3
Rationale | Description: Name of the organisation, institution or group.
Source | NFDI4Health DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept name in dataset Module Design (V3.3) (v3.3)
personal | link
Id | (2022‑11‑28)
Synonym | role_name_personal
Description | Details about the person
### Properties
No 3_0 | 1.11.3
Rationale | Description: Group of items providing information about person(s) contributing to the resource. Additional information: Group of items applicable to personal names.
Source | NFDI4Health
Comment | Cardinality: 1..1, if role_name_type=="Personal"; otherwise 0..0
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept personal in dataset Module Design (V3.3) (v3.3)
type |
Id | (2022‑11‑28)
Synonym | role_name_personal_type
Description | Type of the role
### Properties
No 3_0 | 1.11.3.1
Rationale | Description: Type of the role a person fulllfils. For example, this can be a principal investigator of a study or an author of a document.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Which role does the person fulllfil? Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Contact | Person with knowledge of how to access, troubleshoot, or otherwise field issues related to the resource [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C25461" (Contact Person (Human)) from code system "NCI Metathesaurus"
Principal investigator | A person who is responsible for the scientific and technical direction of the entire study [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C19924" (Principal Investigator (Professional or Occupational Group)) from code system "NCI Metathesaurus"
Creator/Author | (1) A person who brought the item into existence; (2) An author of the resource [DataCite (https://doi.org/10.14454/3w3z-sa82), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C42781" (Author (Human)) from code system "NCI Metathesaurus" code "C115486" (Content Item Creator (Qualitative Concept)) from code system "NCI Metathesaurus"
Sponsor (primary) | (1) A person taking responsibility for and initiating a study; (2) An individual, organization, group or other legal person taking responsibility for securing the arrangements to initiate and/or manage a study (including arrangements to ensure that the study design meets appropriate standards and to ensure appropriate conduct and reporting). In commercial trials, the primary sponsor is normally the main applicant for regulatory authorization to begin the study. It may or may not be the main funder [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "037" (Primary Sponsor) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Sponsor (secondary) | A person who has agreed with the primary sponsor to take responsibility for a study [WHO (https://www.who.int/clinical-trials-registry-platform/unambiguous-trial-identification/the-universal-trial-number-(utn)), NFDI4Health]. | code "C142679" (Secondary Sponsor (Human)) from code system "NCI Metathesaurus"
Sponsor-Investigator | A person both initiating and conducting the study [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C142695" (Sponsor-Investigator (Professional or Occupational Group)) from code system "NCI Metathesaurus"
Data collector | Person/institution responsible for finding or gathering/collecting data under the guidelines of the author(s) or Principal Investigator (PI) [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "038" (Data Collector) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Data curator | Person tasked with reviewing, enhancing, cleaning, or standardizing metadata and the associated data submitted for storage, use, and maintenance within a data centre or repository [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "039" (Data Curator) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Data manager | Person (or organisation with a staff of data managers, such as a data centre) responsible for maintaining the finished resource [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C51820" (Data Manager (Professional or Occupational Group)) from code system "NCI Metathesaurus"
Editor | A person who oversees the details related to the publication format of the resource [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C43368" (Editor (Occupation or Discipline)) from code system "NCI Metathesaurus"
Producer | Typically, a person or organisation responsible for the artistry and form of a media product [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C45336" (Producer (Human)) from code system "NCI Metathesaurus"
Project leader | A person officially designated as head of project team or sub-project team instrumental in the work necessary to development of the resource [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "040" (Project Leader) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Project manager | A person officially designated as manager of a project. Project may consist of one or many project teams and sub-teams [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "041" (Project Manager) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Project member | A person on the membership list of a designated project/project team [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "042" (Project Member) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Related person | A person without a specifically defined role in the development of the resource, but who is someone the author wishes to recognize [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "043" (Related Person) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Researcher | A person without a specifically defined role in the development of the resource, but who is someone the author wishes to recognize [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C0035173" (Research Personnel (Professional or Occupational Group)) from code system "Unified Medical Language System"
Rights holder | Person or institution owning or managing property rights, including intellectual property rights over the resource [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "044" (Rights Holder) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Supervisor | Designated administrator over one or more groups/teams working to produce a resource, or over one or more steps of a development process [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C134832" (Supervisor (Professional or Occupational Group)) from code system "NCI Metathesaurus"
Work package leader | An entity responsible for ensuring the comprehensive contents, versioning, and availability of the Work Package during the development of the resource. A Work Package is a recognized data product, not all of which is included in publication. The package, instead, may include notes, discarded documents, etc. [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "045" (Work Packager Leader) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other | Any person making a significant contribution to the development and/or maintenance of the resource, but whose contribution is not adequately described by any of the other values for “Role type” [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C17649" (Other (Qualitative Concept)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Personal_Roles_NCI_UMLS_Local (version 2023‑08‑25 09:35:12)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept type in dataset Module Design (V3.3) (v3.3)
givenName |
Id | (2022‑11‑28)
Synonym | role_name_personal_given_name
Description | Given name of the person.
### Properties
No 3_0 | 1.11.3.2
Rationale | Description: Given name of the person.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept givenName in dataset Module Design (V3.3) (v3.3)
familyName |
Id | (2022‑11‑28)
Synonym | role_name_personal_family_name
Description | Family name of the person.
### Properties
No 3_0 | 1.11.3.3
Rationale | Description: Family name of the person.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=D
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept familyName in dataset Module Design (V3.3) (v3.3)
title |
Id | (2022‑11‑28)
Synonym | role_name_personal_title
Description | Title of the person.
### Properties
No 3_0 | 1.11.3.4
Rationale | Description: Title of the person.
Source | NFDI4Health DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=D
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Mr. |  | code "C69166" (Mister (Conceptual Entity)) from code system "NCI Metathesaurus"
Ms. |  | code "C69169" (Ms (Conceptual Entity)) from code system "NCI Metathesaurus"
Dr. |  | code "C69164" (Doctor (Conceptual Entity)) from code system "NCI Metathesaurus"
Prof. Dr. |  | code "C69170" (Professor (Conceptual Entity)) from code system "NCI Metathesaurus"
Other |  | code "C17649" (Other (Qualitative Concept)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Role_Name_Personal_Title_NCI (version 2023‑08‑25 09:54:10)
Used by | 0 transactions, 0 templates, inherited 2 times
| This concept is inherited by concept title in dataset Core Metadata Schema (V3.3) This concept is inherited by concept title in dataset Module Design (V3.3) (v3.3)
identifiers | link
Id | (2022‑11‑28)
Synonym | role_name_identifiers
Description | Digital identifier(s) of the person
### Properties
No 3_0 | 1.11.3.5
Rationale | Description: Group of items providing information about digital identifiers of the person.
Source | NFDI4Health
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): no
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept identifiers in dataset Module Design (V3.3) (v3.3)
Identifier |
Id | (2022‑11‑28)
Synonym | identifier
Description | Identifier
### Properties
No 3_0 | 1.11.3.5.1
Rationale | Description: Digital identifier of the person according to a definite scheme.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Preferably, provide an ORCID (https://orcid.org/).
Value Domain | String
Example | 0000-0003-1379-7023
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept Identifier in dataset Module Design (V3.3) (v3.3)
scheme |
Id | (2022‑11‑28)
Synonym | scheme
Description | Which type of identifer is reported?
### Properties
No 3_0 | 1.11.3.5.2
Rationale | Description: Type of the identifier scheme.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): no
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
ORCID | Open Researcher and Contributor ID (ORCID) provides identifiers, i.e. alphanumeric codes, to uniquely identify authors and contributors of scholarly communication; ORCID's website: https://orcid.org/ [NFDI4Health]. | code "080" (ORCID) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
ROR | Research Organization Registry (ROR) provides open, sustainable, usable, and unique identifiers for every research organization in the world; ROR's website:https://ror.org/ [NFDI4Health]. | code "081" (ROR) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
GRID | Global Research Identifier Database (GRID) was an open database of unique research-related organisation identifiers. In 2021 GRID passed the torch to ROR for being the community driven research organisation identifier; GRID's website: https://www.grid.ac/ [NFDI4Health]. | code "082" (GRID) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
ISNI | ISNI (International Standard Name Identifier) is an ISO standard used to uniquely identify persons and organizations; ISNI's website: http://www.isni.org/ [NFDI4Health]. | code "083" (ISNI) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set NFDI4Health_VS_MDS_Role_Name_Identifier_Scheme_Local (version 2023‑09‑22 14:07:54)
Example | ORCID
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept scheme in dataset Module Design (V3.3) (v3.3)
email |
Id | (2022‑11‑28)
Synonym | role_email
Description | Email address
### Properties
No 3_0 | 1.11.4
Rationale | Description: Email address of the person, group of persons or institution/organisation.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=D
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept email in dataset Module Design (V3.3) (v3.3)
phone |
Id | (2022‑11‑28)
Synonym | role_phone
Description | Phone number
### Properties
No 3_0 | 1.11.5
Rationale | Description: Phone number of the person, group of persons or institution/organisation.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=D
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Please, use the International ITU-T E.164-number structure for geographic areas, e.g. +49 (0)153 1112233.
Value Domain | String
Example | +49 (0)153 1112233
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept phone in dataset Module Design (V3.3) (v3.3)
affiliation | link
Id | (2022‑11‑28)
Synonym | role_affiliations
Description | Further information about organisation(s) associated with the role
### Properties
No 3_0 | 1.11.6
Rationale | Description: Group of items providing further information about the organisation(s) associated with the role.
Source | NFDI4Health
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept affiliation in dataset Module Design (V3.3) (v3.3)
name |
Id | (2022‑11‑28)
Synonym | role_affiliation_name
Description | Name of the organisation
### Properties
No 3_0 | 1.11.6.1
Rationale | Description: Name of the organisation associated with the role.
Source | NFDI4Health DataCite [ https://doi.org/10.14454/3w3z-sa82] CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: If you are have already entered the name of the organistion in the property "Name of the organisation/institution/group", please repeat it here.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept name in dataset Module Design (V3.3) (v3.3)
address |
Id | (2022‑11‑28)
Synonym | role_affiliation_address
Description | Address of the organisation
### Properties
No 3_0 | 1.11.6.2
Rationale | Description: Address of the organisation associated with the role.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&mess
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept address in dataset Module Design (V3.3) (v3.3)
webpage |
Id | (2022‑11‑28)
Synonym | role_affiliation_web_page
Description | Web page of the organisation
### Properties
No 3_0 | 1.11.6.3
Rationale | Description: Web page of the organisation associated with the role.
Source | DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&mess
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept webpage in dataset Module Design (V3.3) (v3.3)
identifiers | link
Id | (2022‑11‑28)
Synonym | role_affiliation_identifiers
Description | Digital identifier(s) of the organisation
### Properties
No 3_0 | 1.11.6.4
Rationale | Description: Group of items providing information about identifiers of the organisation.
Source | NFDI4Health
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept identifiers in dataset Module Design (V3.3) (v3.3)
Identifier |
Id | (2022‑11‑28)
Synonym | identifier
Description | Identifier
### Properties
No 3_0 | 1.11.6.4.1
Rationale | Description: Digital identifier of the organisation according to a definite scheme.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Preferably, provide an identifier from ROR (https://ror.org/search).
Value Domain | String
Example | 0259fwx54
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept Identifier in dataset Module Design (V3.3) (v3.3)
scheme |
Id | (2022‑11‑28)
Synonym | scheme
Description | Identifier scheme
### Properties
No 3_0 | 1.11.6.4.2
Rationale | Description: Type of the identifier scheme.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): no
Operationalization | Short input help: Which type of identifer is reported?
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
ROR | Research Organization Registry (ROR) provides open, sustainable, usable, and unique identifiers for every research organization in the world; ROR's website:https://ror.org/ [NFDI4Health]. | code "081" (ROR) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
GRID | Global Research Identifier Database (GRID) was an open database of unique research-related organisation identifiers. In 2021 GRID passed the torch to ROR for being the community driven research organisation identifier; GRID's website: https://www.grid.ac/ [NFDI4Health]. | code "082" (GRID) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
ISNI | ISNI (International Standard Name Identifier) is an ISO standard used to uniquely identify persons and organizations; ISNI's website: http://www.isni.org/ [NFDI4Health]. | code "083" (ISNI) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set NFDI4Health_VS_MDS_Role_Affiliation_Identifier_Scheme_Local (version 2023‑10‑04 07:58:24)
Example | ROR
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept scheme in dataset Module Design (V3.3) (v3.3)
idsAlternative | link
Id | (2022‑11‑28)
Synonym | ids_alternative
Description | Alternative identifiers
### Properties
No 3_0 | 1.12
Rationale | Description: Group of items providing information about identifiers (IDs) assigned to the given resource by another registering systems, e.g. a register of clinical trials or a data repository.
Source | NFDI4Health
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: If the [RESOURCE] is registered in other systems (e.g. a register of clinical trials or a data repository), you can provide corresponding identifier(s) here.
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept idsAlternative in dataset Module Design (V3.3) (v3.3)
scheme |
Id | (2022‑11‑28)
Synonym | type
Description | Type of the register
### Properties
No 3_0 | 1.12.1
Rationale | Description: Type/name of the system where the given resource is already registered.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
DRKS | The identifier provided by the German Clinical Trials Register (DRKS) when a study is registered [NFDI4Health]. | code "098" (DRKS) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
NCT (ClinicalTrials.gov) | The identifier provided by the ClinicalTrials.gov when a study is registered [NFDI4Health]. | code "C5419532" (Clinicaltrials.gov Identifier) from code system "Unified Medical Language System"
ISRCTN | The identifier provided by the ISRCTN registry when a study is registered [NFDI4Health]. | code "099" (ISRCTN) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
EudraCT | The identifier provided by the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) when a study is registered [NFDI4Health]. | code "C4329800" (European Union Drug Regulating Authorities Clinical Trials Database (Intellectual Product)) from code system "Unified Medical Language System"
EUDAMED | The identifier provided by the European Databank on Medical Devices when an object is registered [NFDI4Health]. | code "100" (EUDAMED) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
UTN | The Universal Trial Number used to facilitate the unambiguous identification of clinical trials. The UTN is not a registration number [WHO (https://www.who.int/clinical-trials-registry-platform/unambiguous-trial-identification/the-universal-trial-number-(utn))]. | code "101" (UTN) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
KonsortSWD | The identifier provided by KonsortSWD (https://www.konsortswd.de/ratswd/themen/krisen/corona/) [NFDI4Health]. | code "102" (KonsortSWD) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
MDM Portal | The identifier provided by the MDM Portal (Medical Data Models) (https://www.medizinische-datenmodelle.de/) [NFDI4Health]. | code "103" (MDM Portal) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other | An identifier that is not covered by any of the other values in this list [NFDI4Health]. | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
NFDI4Health |  |
Value Set NFDI4Health_VS_MDS_ID_TYPE_UMLS_Local (version 2023‑10‑04 09:17:37)
Example | DRKS
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept scheme in dataset Module Design (V3.3) (v3.3)
Identifier |
Id | (2022‑11‑28)
Synonym | identifier
Description | Identifier
### Properties
No 3_0 | 1.12.2
Rationale | Description: Identifier (ID) assigned to the given resource by another registering system, e.g. by a register of clinical trials or a data repository.
Source | NFDI4Health DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: E. g., DRKS00021273, NCT04327505, etc.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept Identifier in dataset Module Design (V3.3) (v3.3)
ids | link
Id | (2022‑11‑28)
Synonym | ids
Description | Related publications, datasets, study documents, web pages, etc.
### Properties
No 3_0 | 1.13
Rationale | Description: Group of items providing information about identifiers (IDs) of the resources related to the given resource, e.g. DOIs of publications, datasets, study documents or links to web pages.
Source | NFDI4Health
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: If existing, you can specify identifier(s) of any related resources, e.g. DOIs of publications, datasets, study documents, links to web pages, etc.
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept ids in dataset Module Design (V3.3) (v3.3)
identifier |
Id | (2022‑11‑28)
Synonym | identifier
Description | Identifier of the related resource
### Properties
No 3_0 | 1.13.1
Rationale | Description: Identifier (ID) related to, or associated with, the resource being registered. These can be IDs of related publications, datasets, study documents, web pages, etc.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: a) Publications like journal articles usually have a DOI, e.g. 10.3238/arztebl.2020.0861. b) A link (URL) starting with "http(s)://" to a web page with any additional information can also be provided here.
Value Domain | String
Example | 10.4126/FRL01-006431467
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept identifier in dataset Module Design (V3.3) (v3.3)
scheme |
Id | (2022‑11‑28)
Synonym | type
Description | Type of the identifier
### Properties
No 3_0 | 1.13.2
Rationale | Description: Type of the identifier of the related resource.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
DOI | Digital Object Identifier: a character string used to uniquely identify an object. A DOI name is divided into two parts, a prefix and a suffix, separated by a slash [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C2348291" (Digital Object Identifier (Intellectual Product)) from code system "Unified Medical Language System"
URL | Uniform Resource Locator, also known as web address, is a specific character string that constitutes a reference to a resource. The syntax is: scheme://domain:port/path?qu erystring#fragmentid [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C1710546" (Uniform Resource Locator (Intellectual Product)) from code system "Unified Medical Language System"
arXiv | arXiv identifier: arXiv.org is a repository of preprints of scientific papers in the fields of mathematics, physics, astronomy, computer science, quantitative biology, statistics, and quantitative finance [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "089" (arXiv) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
EAN13 | European Article Number, now renamed International Article Number, but retaining the original acronym, is a 13-digit barcoding standard that is a superset of the original 12-digit Universal Product Code (UPC) system [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "090" (EAN13) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
EISSN | Electronic International Standard Serial Number: ISSN used to identify periodicals in electronic form (eISSN or e-ISSN) [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "091" (EISSN) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Handle | This refers specifically to an ID in the Handle system operated by the Corporation for National Research Initiatives (CNRI) [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C1708320" (Handle - program access (Conceptual Entity)) from code system "Unified Medical Language System"
ISBN | International Standard Book Number: a unique numeric book identifier. There are 2 formats: a 10-digit ISBN format and a 13- digit ISBN [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "092" (ISBN) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
ISSN | International Standard Serial Number: a unique 8-digit number used to identify a print or electronic periodical publication [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "093" (ISSN) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
ISTC | International Standard Text Code: a unique “number” assigned to a textual work. An ISTC consists of 16 numbers and/or letters [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "094" (ISTC) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
LISSN | The linking ISSN or ISSN-L enables collocation or linking among different media versions of a continuing resource [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "095" (LISSN) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
LSID | Life Science Identifiers: a unique identifier for data in the Life Science domain. Format: urn:lsid:authority:namespace:identifier:revision [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C1708696" (Life Sciences Identifier (Conceptual Entity)) from code system "Unified Medical Language System"
PMID | PubMed identifier: a unique number assigned to each PubMed record [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C4288349" (PubMed Identifier for Citation Used in Study (Intellectual Product)) from code system "Unified Medical Language System"
PURL | Persistent Uniform Resource Locator. A PURL has three parts: (1) a protocol, (2) a resolver address, and (3) a name [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "096" (PURL) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
URN | Uniform Resource Name: a unique and persistent identifier of an electronic document. The syntax is: urn:< NID>:<NSS>. The leading urn: sequence is case-insensitive, <NID> is the namespace identifier, <NSS> is the namespace-specific string [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "C2349021" (Uniform Resource Name (Intellectual Product)) from code system "Unified Medical Language System"
w3id | Permanent identifier for Web applications. Mostly used to publish vocabularies and ontologies. The letters ‘w3’ stand for “World Wide Web” [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "097" (w3id) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other | An identifier that is not covered by any of the other values in this list [NFDI4Health]. | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Identifier_Type_Related_Artifact_UMLS_Local (version 2023‑10‑26 09:58:11)
Example | DOI
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept scheme in dataset Module Design (V3.3) (v3.3)
date |
Id | (2022‑11‑28)
Synonym | date
Description | Date of ID assignment
### Properties
No 3_0 | 1.13.3
Rationale | Description: Date when the identifier of the related resource was assigned. Additional information: Preferred date format: DD.MM.YYYY
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Date
Used by | 0 transactions, 0 templates, inherited 2 times
| This concept is inherited by concept date in dataset Core Metadata Schema (V3.3) This concept is inherited by concept date in dataset Module Design (V3.3) (v3.3)
relationType |
Id | (2022‑11‑28)
Synonym | relation_type
Description | Relationship between this [RESOURCE] (A) and the related resource (B)?
### Properties
No 3_0 | 1.13.4
Rationale | Description: Relationship between the resource being registered (A) and the related resource (B).
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
A is cited by B | The resource B (a related resource) includes the resource A (the resource being registered in the portal) in a citation [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "055" (A is cited by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A cites B | A includes B in a citation [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "056" (A cites B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is supplement to B | A is a supplement to B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "108" (A is supplement to B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is supplemented by B | B is a supplement to A [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "057" (A is supplemented by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is continued by B | A is continued by the work B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "058" (A is continued by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A continues B | A is a continuation of the work B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "109" (A continues B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is described by B | A is described by B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "059" (A is described by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A describes B | A describes B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "060" (A describes B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A has metadata B | A has additional metadata B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "110" (A has metadata B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is metadata for B | Additional metadata A for a B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "061" (A is metadata for B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A has version B | A has a version (B) [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "062" (A has version B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is version of B | A is a version of B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "063" (A is version of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is new version of B | A is a new edition of B, where the new edition has been modified or updated [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "111" (A is new version of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is previous version of B | A is a previous edition of B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "064" (A is previous version of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is part of B | A is a portion of B; may be used for elements of a series [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "065" (A is part of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A has part B | A includes the part B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "112" (A has part B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is referenced by B | A is used as a source of information by B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "066" (A is referenced by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A references B | B is used as a source of information for A [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "113" (A references B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is documented by B | B is documentation about/ explaining A; e.g. points to software documentation [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "067" (A is documented by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A documents B | A is documentation about B; e.g. points to software documentation [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "114" (A documents B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is compiled by B | B is used to compile or create A [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "068" (A is compiled by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A compiles B | B is the result of a compile or creation event using A [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "069" (A compiles B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is variant form of B | A is a variant or different form of B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "070" (A is variant form of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is original form of B | A is the original form of B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "071" (A is original form of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is identical to B | A is identical to B, for use when there is a need to register two separate instances of the same resource [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "072" (A is identical to B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is reviewed by B | A is reviewed by B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "073" (A is reviewed by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A reviews B | A is a review of B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "074" (A reviews B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is derived from B | B is a source upon which A is based [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "115" (A is derived from B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is source of B | A is a source upon which B is based [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "075" (A is source of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is required by B | A is required by B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "076" (A is required by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A requires B | A requires B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "077" (A requires B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is obsoleted by B | A is replaced by B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "078" (A is obsoleted by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A obsoletes B | A replaces B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "079" (A obsoletes B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set required NFDI4Health_VS_MDS_Relation_Type_Ids_Local (version 2023‑08‑25 10:26:30)
Example | A is part of B
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept relationType in dataset Module Design (V3.3) (v3.3)
resourceTypeGeneral |
Id | (2022‑11‑28)
Synonym | resource_type_general
Description | Type of the related resource
### Properties
No 3_0 | 1.13.5
Rationale | Description: Type of the related resource, e.g. journal article, dataset, text, etc.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select one value from the list. For example,. a journal article, dataset, text, etc.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Audiovisual |  | code "C19695" (Audiovisual Material (Manufactured Object)) from code system "NCI Metathesaurus"
Book |  | code "C16360" (Book (Manufactured Object)) from code system "NCI Metathesaurus"
Book chapter |  | code "C0005990" (Book Chapter (Intellectual Product)) from code system "Unified Medical Language System"
Collection |  | code "C45261" (Item Collection (Idea or Concept)) from code system "NCI Metathesaurus"
Computational notebook |  | code "051" (Computational Notebook) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Conference paper |  | code "C0814814" (Conference Paper (Intellectual Product)) from code system "Unified Medical Language System"
Conference proceeding |  | code "C0009664" (Conference Proceedings as Topic (Intellectual Product)) from code system "Unified Medical Language System"
Data paper |  | code "052" (Data Paper) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Dataset |  | code "C47824" (Data Set (Idea or Concept)) from code system "NCI Metathesaurus"
Dissertation |  | code "C0376645" (Academic Dissertation (Intellectual Product)) from code system "Unified Medical Language System"
Event |  | code "C25499" (Event (Event)) from code system "NCI Metathesaurus"
Image |  | code "C48179" (Image (Entity)) from code system "NCI Metathesaurus"
Interactive resource |  | code "053" (Interactive Resource) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Journal |  | code "C40976" (Journal (Intellectual Product)) from code system "NCI Metathesaurus"
Journal article |  | code "C0282420" (Journal Article (Intellectual Product)) from code system "Unified Medical Language System"
Model |  | code "C16866" (Model (Intellectual Product)) from code system "NCI Metathesaurus"
Output management plan |  | code "054" (Output Management Plan) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Peer review |  | code "C16963" (Peer Review (Occupational Activity)) from code system "NCI Metathesaurus"
Physical object |  | code "C0347997" (Physical object) from code system "Unified Medical Language System"
Preprint |  | code "C4704708" (Preprint) from code system "Unified Medical Language System"
Report |  | code "C25375" (Report (Intellectual Product)) from code system "NCI Metathesaurus"
Service |  | code "C47920" (Service (Activity)) from code system "NCI Metathesaurus"
Software |  | code "C17146" (Computer Program (Intellectual Product)) from code system "NCI Metathesaurus"
Sound |  | code "C64383" (Sound (Natural Phenomenon or Process)) from code system "NCI Metathesaurus"
Standard |  | code "C81893" (Standard (Intellectual Product)) from code system "NCI Metathesaurus"
Text |  | code "C25704" (Text (Manufactured Object)) from code system "NCI Metathesaurus"
Workflow |  | code "C42753" (Workflow (Conceptual Entity)) from code system "NCI Metathesaurus"
Other |  | code "C17649" (Other (Qualitative Concept)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Resource_Type_General_NCI_UMLS_Local (version 2022‑06‑27 14:09:14)
Example | Text
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept resourceTypeGeneral in dataset Module Design (V3.3) (v3.3)
idsNfdi4health | link
Id | (2022‑11‑28)
Synonym | ids_nfdi4health
Description | Related (sub-)studies, study documents, etc. registered on this portal
### Properties
No 3_0 | 1.14
Rationale | Description: Group of items providing information about related resources registered on this portal.
Source | NFDI4Health
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Does the [RESOURCE] have any related resources registered on this portal?
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept idsNfdi4health in dataset Module Design (V3.3) (v3.3)
identifier |
Id | (2022‑11‑28)
Synonym | identifier
Description | Identifier of the related resource
### Properties
No 3_0 | 1.14.1
Rationale | Description: Identifier (ID) of the related resource assigned on this portal.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Example | 39
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept identifier in dataset Module Design (V3.3) (v3.3)
relationType |
Id | (2022‑11‑28)
Synonym | relation_type
Description | Relationship between this [RESOURCE] (A) and the related resource (B)?
### Properties
No 3_0 | 1.14.2
Rationale | Description: Relationship between the resource being registered (A) and the related resource (B).
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
A is part of B | A is a portion of B; may be used for elements of a series [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "065" (A is part of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A has part B | A includes the part B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "112" (A has part B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is supplement to B | A is a supplement to B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "108" (A is supplement to B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is supplemented by B | B is a supplement to A [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "057" (A is supplemented by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is continued by B | A is continued by the work B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "058" (A is continued by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A continues B | A is a continuation of the work B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "109" (A continues B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is described by B | A is described by B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "059" (A is described by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A describes B | A describes B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "060" (A describes B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A has version B | A has a version (B) [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "062" (A has version B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is version of B | A is a version of B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "063" (A is version of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is new version of B | A is a new edition of B, where the new edition has been modified or updated [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "111" (A is new version of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is previous version of B | A is a previous edition of B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "064" (A is previous version of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is variant form of B | A is a variant or different form of B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "070" (A is variant form of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is original form of B | A is the original form of B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "071" (A is original form of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is identical to B | A is identical to B, for use when there is a need to register two separate instances of the same resource [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "072" (A is identical to B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is derived from B | B is a source upon which A is based [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "DRIV" (is derived from) from code system "HL7ActRelationshipType"
A is source of B | A is a source upon which B is based [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "075" (A is source of B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A is obsoleted by B | A is replaced by B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "078" (A is obsoleted by B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
A obsoletes B | A replaces B [DataCite (https://doi.org/10.14454/3w3z-sa82)]. | code "079" (A obsoletes B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set NFDI4Health_VS_MDS_Relation_Type_Ids_Nfdi_Local (version 2023‑08‑25 10:36:39)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept relationType in dataset Module Design (V3.3) (v3.3)
nutritionalData |
Id | (2022‑11‑28)
Synonym | nutritional_data
Description | Nutritional data collected?
### Properties
No 3_0 | 1.15
Rationale | Description: Indication whether nutritional data was collected by the resource.
Source | NFDI4Health
Comment | Cardinality: 1..1, if resource_type == ("Study" OR "Substudy/Data collection") AND provenance.data_source != "Manually collected"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Boolean
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept nutritionalData in dataset Module Design (V3.3) (v3.3)
chronicDiseases |
Id | (2022‑11‑28)
Synonym | chronic_diseases
Description | Chronic diseases included?
### Properties
No 3_0 | 1.16
Rationale | Description: Indication whether chronic diseases were addressed by the resource.
Source | NFDI4Health
Comment | Cardinality: 1..1, if provenance.data_source != "Manually collected"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Boolean
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept chronicDiseases in dataset Module Design (V3.3) (v3.3)
studyDesign | link
Id | (2022‑11‑28)
Synonym | study_design
Description | Characteristics of the [RESOURCE]
### Properties
No 3_0 | 1.17
Rationale | Description: Group of items providing information about the characteristics of a study or a substudy. Additional information: Group of items applicable only to studies and substudies.
Source | NFDI4Health
Comment | Cardinality: 1..1, if resource_type == ("Study" OR "Substudy/Data collection"); otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
primaryDesign |
Id | (2022‑11‑28)
Synonym | study_primary_design
Description | Is it an interventional or non-interventional study?
### Properties
No 3_0 | 1.17.1
Rationale | Description: Non-interventional study design refers to a study that does not aim to alter study outcomes of interest. Interventional study design refers to a study that aims to alter study outcomes of interest.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select between non-interventional and interventional study design.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Non-interventional | (1) A study that does not aim to alter study outcomes of interest; (2) A study in which the assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health]. | code "131" (Non-interventional) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Interventional | (1) A study that aims to alter study outcomes of interest; (2) Studies in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health]. | code "130" (Interventional) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set required NFDI4Health_VS_MDS_Study_Primary_Design_Local (version 2023‑10‑25 11:20:52)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept primaryDesign in dataset Core Metadata Schema (V3.3)
studyType | link
Id | (2022‑11‑28)
Synonym | study_type
Description | Specification of study type
### Properties
No 3_0 | 1.17.2
Rationale | Description: Group of items providing information about the study type.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields] DDI [ https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html] MIABIS [ https://github.com/BBMRI-ERIC/miabis]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept studyType in dataset Core Metadata Schema (V3.3)
interventional |
Id | (2022‑11‑28)
Synonym | study_type_interventional
Description | Specification of study type
### Properties
No 3_0 | 1.17.2.1
Rationale | Description: The strategy for assigning interventions to participants.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..*, if study_primary_design == "Interventional"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select all that apply. If "Other" is selected, you can specify the study type in the field "Additional information about the study".
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Single group | Clinical trials with a single arm [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "133" (Single Group) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Parallel | Participants are assigned to one of two or more groups in parallel for the duration of the study [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "134" (Parallel) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Crossover | Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "135" (Crossover) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Factorial | Two or more interventions, each alone and in combination, are evaluated in parallel against a control group [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "136" (Factorial) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Sequential | Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "137" (Sequential) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other | A study type that is not covered by any of the other values in this list [NFDI4Health]. | code "138" (Other (interventional)) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Unknown | The study type is unknown [NFDI4Health]. | code "139" (Unknown (interventional)) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set required NFDI4Health_VS_MDS_Study_Type_Interventional_Local (version 2023‑10‑25 13:12:42)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept interventional in dataset Core Metadata Schema (V3.3)
nonInterventional |
Id | (2022‑11‑28)
Synonym | study_type_non_interventional
Description | Specification of study type
### Properties
No 3_0 | 1.17.2.2
Rationale | Description: The primary strategy for participant identification and follow-up.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields] DDI [ https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html] MIABIS [ https://github.com/BBMRI-ERIC/miabis]
Comment | Cardinality: 1..*, if study_primary_design == "Non-interventional"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select all that apply. If "Other" is selected, you can specify the study type in the field "Additional information about the study".
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Case-control | Group of individuals with specific characteristics (for example, conditions or exposures) compared to group(s) with different characteristics, but otherwise similar. A case-control study design compares two groups of subjects: those with the disease or condition under study (cases) and a very similar group of subjects who do not have the disease or condition (controls) [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary), MIABIS (https://github.com/BBMRI-ERIC/miabis)]. | code "141" (Case-control) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Nested case-control | (1) A study in which a group or cohort of individuals is followed for a certain length of time or until a specific outcome is reached. Studies of this type incorporate the strengths of both cohort and case-control studies but eliminates a portion of the methodologic challenges inherent in both types of studies; (2) For each identified case one or more controls are selected, which are still under observation in a cohort study at the time when the case developed the disease of interest [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "140" (Case-control) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Case-only | Single group of individuals with specific characteristics [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "003" (Case-only) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Case-crossover | Characteristics of case immediately prior to disease onset (sometimes called the hazard period) compared to characteristics of same case at a prior time (that is, control period) [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "142" (Case-crossover) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Ecologic or community studies | Geographically defined populations, such as countries or regions within a country, compared on a variety of environmental (for example, air pollution intensity, hours of sunlight) and/or global measures not reducible to individual level characteristics (for example, healthcare system, laws or policies median income, average fat intake, disease rate) [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "143" (Ecologic or community studies) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Family-based | Studies conducted among family members, such as genetic studies within families or twin studies and studies of family environment [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "144" (Family-based) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Twin study | Twin studies measure the contribution of genetics (as opposed to environment) to a given trait or condition of interest [MIABIS (https://github.com/BBMRI-ERIC/miabis)]. | code "145" (Twin study) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Cohort | (1) Group of individuals, initially defined and composed, with common characteristics (for example, condition, birth year), who are examined or traced over a given time period; (2) Data collected over time from the same cohort of respondents. The individuals in the cohort are connected in some way or have shared some significant experience within a given period. In some cases, the samples may differ between waves but are drawn from the same cohort. Examples: birth year, disease (clinical trials), common problem (intervention studies), education, employment, family formation, participation in an event; (3) A form of longitudinal study for the analysis of risk factors following a group of people who do not have a disease, and uses correlations to determine the absolute risk of subject contraction [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary), MIABIS (https://github.com/BBMRI-ERIC/miabis), DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "146" (Cohort) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Case-cohort | A random subcohort from the overall cohort is picked and all cases (either within this random subcohort or outside) will be selected as well. Also a suitable design for the investigation of several diseases in parallel. | code "004" (Case-cohort studies) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Birth cohort | A cohort study for which the subjects are followed from the time of birth usually including information about gestation and follow up [MIABIS (https://github.com/BBMRI-ERIC/miabis)]. | code "147" (Birth cohort) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Trend | Data are collected from different samples or different groups of people from the same population at several points in time, using at least partly the same set of questions/variables. Conclusions are drawn for the population. Examples: European Social Survey (ESS), national longitudinal crime surveys [DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "005" (Trend) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Panel | Data are collected over time from, or about, the same sample of respondents. Differs from cohort data in that the selection of respondents is not based on their being connected in some way or having shared some significant experience [DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "148" (Panel) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Longitudinal | (1) Data collected repeatedly over time to allow studying change in a population. At least some of the questions or modules are repeated over waves. Use the broad term when none of the subterms is suitable; (2) Research studies involving repeated observations of the same entity over time. In the biobank context, longitudinal studies sample a group of people in a given time period, and study them at intervals by the acquisition and analyses of data and/or samples over time [MIABIS (https://github.com/BBMRI-ERIC/miabis), DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "149" (Longitudinal) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Cross-section | (1) Data collected by observing subjects within the study period, without regard to changes over time. May include more than one collection event. Analysis of cross-sectional data often consists in comparing the differences and similarities among subjects; (2) A type of observational study that involves data collection from a population, or a representative subset, at one specific point in time [MIABIS (https://github.com/BBMRI-ERIC/miabis), DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "150" (Cross-section) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Cross-section ad-hoc follow-up | Data are collected at one point in time to complete information collected in a previous cross-sectional study; the decision to collect follow-up data was not included in the original study design [DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "006" (Cross-section ad-hoc follow-up) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Time series | Data are collected repeatedly over time to study change in observations. These are typically "objective" measurements of phenomena that can be observed externally, as opposed to attitudes/opinions or feelings. Examples may include economic/financial indicators, natural/meteorological phenomena, vital statistics, etc. [DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "151" (Time series) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Quality control | A quality control testing study design type is where some aspect of the experiment is quality controlled for the purposes of quality assurance [MIABIS (https://github.com/BBMRI-ERIC/miabis)]. | code "007" (Quality control) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Registry | An observational study which includes an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, health care services, and/or procedures) and that serves a predetermined scientific, clinical, or policy purpose [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health] | code "152" (Registry) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other | A study type that is not covered by any of the other values in this list [NFDI4Health]. | code "153" (Other (non-interventional)) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Unknown | The study type is unknown [NFDI4Health]. | code "154" (Unknown (non interventional)) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set required NFDI4Health_VS_MDS_Study_Type_Non_Interventional_Local (version 2023‑10‑25 13:53:47)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept nonInterventional in dataset Core Metadata Schema (V3.3)
studyConditions | link
Id | (2022‑11‑28)
Synonym | study_conditions
Description | Primary health condition(s), disease(s) or focus of the study
### Properties
No 3_0 | 1.17.3
Rationale | Description: Group of items providing information about primary health condition(s) or disease(s) considered in the study, or the focus of the study (e.g. medication, food, therapy, device, etc.).
Source | NFDI4Health
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept studyConditions in dataset Core Metadata Schema (V3.3)
label |
Id | (2022‑11‑28)
Synonym | study_conditions_label
Description | Name of the primary health condition, disease or focus of the study
### Properties
No 3_0 | 1.17.3.1
Rationale | Description: Name of primary health condition or disease considered in the study, or the focus of the study (e.g. medication, food, therapy, device, etc.). Additional information: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD, etc.) is preferred. However, also self-assigned terms are allowed.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Preferably, use terms from SNOMED CT (https://browser.ihtsdotools.org).
Value Domain | String
Example | SARS-CoV-2
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept label in dataset Core Metadata Schema (V3.3)
classification |
Id | (2022‑11‑28)
Synonym | study_conditions_classification
Description | Terminology/classification
### Properties
No 3_0 | 1.17.3.2
Rationale | Description: Terminology/classification used for the health condition, diesease or focus.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: If used, name of the terminology/classification.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
MeSH | MeSH (Medical Subject Headings) is the NLM controlled vocabulary thesaurus. To search for terms, the following service can be used: https://meshb.nlm.nih.gov/ [NFDI4Health]. | code "C1135584" (Medical Subject Headings (Intellectual Product)) from code system "Unified Medical Language System"
ICD-10 | International Statistical Classification of Diseases and Related Health Problems 10th Revision. To search for terms, the follwoing service can be used: https://icd.who.int/browse10/2016/en [NFDI4Health]. | code "C1137110" (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) (Intellectual Product)) from code system "Unified Medical Language System"
MedDRA | MedDRA (Medical Dictionary for Regulatory Activities) is a rich and highly specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans. For more details, please visit: https://www.meddra.org/ [NFDI4Health]. | code "C1140263" (Medical Dictionary for Regulatory Activities Terminology (MedDRA) (Intelectual Product)) from code system "Unified Medical Language System"
SNOMED CT | SNOMED CT (SNOMED Clinical Terms) is a systematically organized computer-processable collection of medical terms providing codes, terms, synonyms and definitions used in clinical documentation and reporting. To search for terms, the following service can be used: https://browser.ihtsdotools.org/?perspective=full&conceptId1=408579009&edition=MAIN/2022-08-31&release=&languages=en [NFDI4Health]. | code "C1623497" (Systematized Nomenclature of Medicine Clinical Terms (Intellectual Product)) from code system "Unified Medical Language System"
Other vocabulary | A vocabulary that is not covered by any of the other values in this list [NFDI4Health]. | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Free text | A controlled vocabulary was not used for the provided terms [NFDI4Health]. | code "C2348713" (Free Text Format (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Study_Conditions_Classification_UMLS (version 2023‑08‑25 12:19:37)
Example | SNOMED CT
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept classification in dataset Core Metadata Schema (V3.3)
code |
Id | (2022‑11‑28)
Synonym | study_conditions_classification_code
Description | Code ---- If known, code of the health condition, disease or focus in the terminology/classification used
### Properties
No 3_0 | 1.17.3.3
Rationale | Description: Code of the health condition, disease, focus in the terminology/classification used.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: If found, the code from the terminology/classification used.
Value Domain | String
Example | http://snomed.info/id/840533007
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept code in dataset Core Metadata Schema (V3.3)
studyGroupsOfDiseases | link
Id | (2022‑11‑28)
Synonym | study_groups_of_diseases
Description | Which groups of diseases or conditions were the data collected on?
### Properties
No 3_0 | 1.17.4
Rationale | Description: Group of items providing information about groups of diseases or conditions on which the data were collected in the study.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept studyGroupsOfDiseases in dataset Core Metadata Schema (V3.3)
generally |
Id | (2022‑11‑28)
Synonym | study_groups_of_diseases_generally
Description | Which groups of diseases or conditions were the data collected on?
### Properties
No 3_0 | 1.17.4.1
Rationale | Description: Groups of diseases or conditions on which the data were collected in the study. Additional information: The values originate from the WHO's International Statistical Classification of Diseases and Related Health Problems, 11th Revision (ICD-11).
Source | ICD-11 [ https://icd.who.int/browse11/l-m/en]
Comment | Cardinality: 1..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select all that apply. For more information about the groups of diseases/conditions, visit the WHO's ICD-11 homepage: https://icd.who.int/en.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Certain infectious or parasitic diseases (01) |  | code "I" (Certain infectious and parasitic diseases) from code system "ICD-10"
Neoplasms (02) |  | code "II" (Neoplasms) from code system "ICD-10"
Diseases of the blood or blood-forming organs (03) |  | code "III" (Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism) from code system "ICD-10"
Diseases of the immune system (04) |  | code "III" (Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism) from code system "ICD-10"
Endocrine, nutritional or metabolic diseases (05) |  | code "IV" (Endocrine, nutritional and metabolic diseases) from code system "ICD-10"
Mental, behavioural or neurodevelopmental disorders (06) |  | code "V" (Mental and behavioural disorders) from code system "ICD-10"
Sleep-wake disorders (07) |  | code "G47.2" (Disorders of the sleep-wake schedule) from code system "ICD-10"
Diseases of the nervous system (08) |  | code "VI" (Diseases of the nervous system) from code system "ICD-10"
Diseases of the visual system (09) |  | code "VII" (Diseases of the eye and adnexa) from code system "ICD-10"
Diseases of the ear or mastoid process (10) |  | code "VIII" (Diseases of the ear and mastoid process) from code system "ICD-10"
Diseases of the circulatory system (11) |  | code "IX" (Diseases of the circulatory system) from code system "ICD-10"
Diseases of the respiratory system (12) |  | code "X" (Diseases of the respiratory system) from code system "ICD-10"
Diseases of the digestive system (13) |  | code "XI" (Diseases of the digestive system) from code system "ICD-10"
Diseases of the skin (14) |  | code "XII" (Diseases of the skin and subcutaneous tissue) from code system "ICD-10"
Diseases of the musculoskeletal system or connective tissue (15) |  | code "XIII" (Diseases of the musculoskeletal system and connective tissue) from code system "ICD-10"
Diseases of the genitourinary system (16) |  | code "XIV" (Diseases of the genitourinary system) from code system "ICD-10"
Conditions related to sexual health (17) |  | code "161" (Conditions related to sexual health) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Pregnancy, childbirth or the puerperium (18) |  | code "XV" (Pregnancy, childbirth and the puerperium) from code system "ICD-10"
Certain conditions originating in the perinatal period (19) |  | code "XVI" (Certain conditions originating in the perinatal period) from code system "ICD-10"
Developmental anomalies (20) |  | code "XVII" (Congenital malformations, deformations and chromosomal abnormalities) from code system "ICD-10"
Symptoms, signs or clinical findings, not elsewhere classified (21) |  | code "XVIII" (Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified) from code system "ICD-10"
Injury, poisoning or certain other consequences of external causes (22) |  | code "XIX" (Injury, poisoning and certain other consequences of external causes) from code system "ICD-10"
External causes of morbidity or mortality (23) |  | code "XX" (External causes of morbidity and mortality) from code system "ICD-10"
Factors influencing health status or contact with health services (24) |  | code "XXI" (Factors influencing health status and contact with health services) from code system "ICD-10"
Other |  | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Not applicable |  | code "C1272460" (Not Applicable (Qualitative Concept)) from code system "Unified Medical Language System"
Unknown |  | code "C0439673" (Unknown (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Study_Groups_Of_Diseases_Generally_ICD10_UMLS_Local (version 2023‑10‑26 10:13:39)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept generally in dataset Core Metadata Schema (V3.3)
conditions |
Id | (2022‑11‑28)
Synonym | study_diseases_conditions
Description | On which other diseases or conditions were the data collected?
### Properties
No 3_0 | 1.17.4.2
Rationale | Description: Other diseases or conditions on which the data were collected in the study. Additional information: The values originate from the WHO's International Statistical Classification of Diseases and Related Health Problems, 11th Revision (ICD-11).
Source | ICD-11 [ https://icd.who.int/browse11/l-m/en] NFDI4Health UC 5.2 requirements
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: For more information about the groups of diseases/conditions, visit the WHO's ICD-11 homepage: https://icd.who.int/en.
Value Domain | String
Example | Values are based on lower level ICD-11
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept conditions in dataset Core Metadata Schema (V3.3)
mortalityData |
Id | (2022‑11‑28)
Synonym | mortality_data
Description | Were mortality data collected?
### Properties
No 3_0 | 1.17.5
Rationale | Description: Mortality data.
Source | NFDI4Health UC 5.2 requirements
Comment | Cardinality: 0..1, if study_type_non_interventional == ("Longitudinal" OR "Cohort" OR "Case-cohort" OR "Birth cohort" OR "Trend" OR "Panel"); otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Yes, vital status only (cause of death missing) |  | code "C25717" (Vital Status) from code system "NCI Metathesaurus"
Yes, with cause of death |  | code "C81239" (Cause of Death) from code system "NCI Metathesaurus"
No |  | code "C49487" (No (Classification)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Mortality_Data_NCI (version 2023‑08‑28 21:27:20)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept mortalityData in dataset Core Metadata Schema (V3.3)
ethicsCommiteeApproval |
Id | (2022‑11‑28)
Synonym | study_ethics_committee_approval
Description | Status of the ethics committee approval
### Properties
No 3_0 | 1.17.6
Rationale | Description: Status of the study approval from the (leading) ethics committee.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Request for approval not yet submitted |  | code "026" (Request for approval not yet submitted) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Request for approval submitted, approval pending |  | code "C1611271" (Pending - status (Temporal Concept)) from code system "Unified Medical Language System"
Request for approval submitted, approval granted |  | code "C0205540" (Approved (Qualitative Concept)) from code system "Unified Medical Language System"
Request for approval submitted, exempt granted |  | code "C2348482" (Exemption (Conceptual Entity)) from code system "Unified Medical Language System"
Request for approval submitted, approval denied |  | code "C0332319" (Denied (qualifier) (Qualitative Concept)) from code system "Unified Medical Language System"
Approval not required |  | code "C1611645" (Not Required (Idea or Concept)) from code system "Unified Medical Language System"
Study withdrawn prior to decision on approval |  | code "027" (Study withdrawn prior to decision on approval) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Unknown status of request approval |  | code "C0439673" (Unknown (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Study_Ethics_Committee_Approval_UMLS_Local (version 2023‑08‑28 21:32:56)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept ethicsCommiteeApproval in dataset Core Metadata Schema (V3.3)
status |
Id | (2022‑11‑28)
Synonym | study_status
Description | Overall study status
### Properties
No 3_0 | 1.17.7
Rationale | Description: Overall status of the study. Additional information: If at least one study site in a multicenter study has the status "Ongoing," then the overall status for the study must be "Ongoing".
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
At the planning stage |  | code "01" (At the planning stage) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (I): Recruitment ongoing, but data collection not yet started |  | code "02" (Ongoing (I) - Recruitment ongoing, but data collection not yet started) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (II): Recruitment and data collection ongoing |  | code "03" (Ongoing (II) - Recruitment and data collection ongoing) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (III): Recruitment completed, but data collection ongoing |  | code "04" (Ongoing (III) - Recruitment completed, but data collection ongoing) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing |  | code "05" (Ongoing (IV) - Recruitment and data collection completed, but data quality management ongoing) from code system "NFDI4Health_CS_MDS_Study_Status"
Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume |  | code "06" (Suspended - Recruitment, data collection, or data quality management, halted, but potentially will resume) from code system "NFDI4Health_CS_MDS_Study_Status"
Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume |  | code "07" (Terminated - Recruitment, data collection, data and quality management halted prematurely and will not resume) from code system "NFDI4Health_CS_MDS_Study_Status"
Completed: Recruitment, data collection, and data quality management completed normally |  | code "08" (Completed - Recruitment, data collection, and data quality management completed normally) from code system "NFDI4Health_CS_MDS_Study_Status"
Other |  | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Study_Overall_Status_UMLS_Local (version 2023‑08‑28 21:45:05)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept status in dataset Core Metadata Schema (V3.3)
statusWhenIntervention |
Id | (2022‑11‑28)
Synonym | study_status_when_intervention
Description | Do participants receive an intervention?
### Properties
No 3_0 | 1.17.8
Rationale | Description: Specification whether study participants receive intervention or have completed it but are still being followed according to the primary objective of the study.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1, if study_primary_degin == "Interventional" AND study_status == ("At the planning stage" OR "Ongoing (I): Recruitment ongoing, but data collection not yet started" OR "Ongoing (II): Recruitment and data collection ongoing" OR "Ongoing (III): Recruitment completed, but data collection ongoing" OR "Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing"); otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Intervention ongoing |  | code "014" (Intervention ongoing) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Intervention completed, follow-up ongoing |  | code "015" (Intervention completed, follow-up ongoing) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set required NFDI4Health_VS_MDS_Study_Status_When_Intervention_Local (version 2023‑09‑05 19:39:49)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept statusWhenIntervention in dataset Core Metadata Schema (V3.3)
stageStopped |
Id | (2022‑11‑28)
Synonym | study_status_halted_stage
Description | At what stage was the study stopped?
### Properties
No 3_0 | 1.17.9
Rationale | Description: If the study was stopped prematurely, specification of the stage at what it was halted.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1, if study_status == ("Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume" OR "Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume"); otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
At the planning stage |  | code "01" (At the planning stage) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (I): Recruitment ongoing, but data collection not yet started |  | code "02" (Ongoing (I) - Recruitment ongoing, but data collection not yet started) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (II): Recruitment and data collection ongoing |  | code "03" (Ongoing (II) - Recruitment and data collection ongoing) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (III): Recruitment completed, but data collection ongoing |  | code "04" (Ongoing (III) - Recruitment completed, but data collection ongoing) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing |  | code "05" (Ongoing (IV) - Recruitment and data collection completed, but data quality management ongoing) from code system "NFDI4Health_CS_MDS_Study_Status"
Value Set NFDI4Health_VS_MDS_Study_Status_Halted_Stage_Local (version 2023‑09‑05 20:02:19)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept stageStopped in dataset Core Metadata Schema (V3.3)
reasonStopped |
Id | (2022‑11‑28)
Synonym | study_status_halted_reason
Description | Reason why the study was stopped
### Properties
No 3_0 | 1.17.10
Rationale | Description: If the study was stopped prematurely, specification of the reason(s) why it was halted.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1, if study_status == ("Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume" OR "Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume"); otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: E.g., accrual goal met / closed due to toxicity / closed due to lack of study progress / temporarily-closed per study design /etc.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept reasonStopped in dataset Core Metadata Schema (V3.3)
statusEnrollingByInvitation |
Id | (2022‑11‑28)
Synonym | study_status_enrolling_by_invitation
Description | Are participants enrolled by invitation?
### Properties
No 3_0 | 1.17.11
Rationale | Description: Specification whether study participants have been selected from a predetermined population or enrolled by invitation.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Yes |  | code "373066001" (Yes (qualifier value)) from code system "SNOMED Clinical Terms"
No |  | code "373067005" (No (qualifier value)) from code system "SNOMED Clinical Terms"
Not applicable |  | code "385432009" (Not applicable (qualifier value)) from code system "SNOMED Clinical Terms"
Value Set required NFDI4Health_VS_MDS_Yes_No_Not_Applicable_SNOMEDCT (version 2023‑08‑28 21:57:28)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept statusEnrollingByInvitation in dataset Core Metadata Schema (V3.3)
recruitmentStatusRegister |
Id | (2022‑11‑28)
Synonym | study_recruitment_status_register
Description | Overall recruitment status of the study from the register of clinical trials
### Properties
No 3_0 | 1.17.12
Rationale | Description: Overall recruitment status of the study as indicated in the corresponding register of clinical trials. Additional information: The item applies only to studies automatically uploaded from the registers of clinical trials.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Not yet recruiting | Participants are not yet being recruited [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "022" (Not yet recruiting) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Recruiting | Participants are currently being recruited, whether or not any participants have yet been enrolled [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C0814875" (recruiting and enrolling subjects (Research Activity)) from code system "Unified Medical Language System"
Enrolling by invitation | Participants are being (or will be) selected from a predetermined population [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "023" (Enrolling by invitation) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Active, not recruiting | Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "024" (Active, not recruiting) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Completed | The study has concluded normally [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C1556116" (completed - ActStatus (Idea or Concept)) from code system "Unified Medical Language System"
Suspended | Study halted prematurely but potentially will resume [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C1553389" (Act Status - suspended (Idea or Concept)) from code system "Unified Medical Language System"
Terminated | Study halted prematurely and will not resume [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C1609614" (aborted - ActStatus (Functional Concept)) from code system "Unified Medical Language System"
Withdrawn | Study halted prematurely, prior to enrollment of first participant [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "025" (Withdrawn) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other | A recruitment status that is not covered by any of the other values in this list [NFDI4Health]. | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Study_Recruitment_Status_Register_UMLS_Local (version 2023‑08‑28 22:50:26)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept recruitmentStatusRegister in dataset Core Metadata Schema (V3.3)
studyStartDate |
Id | (2022‑11‑28)
Synonym | study_start_date
Description | Start date of data collection for the study
### Properties
No 3_0 | 1.17.13
Rationale | Description: Start date of data collection for the study. Additional information: Preferred date format: DD.MM.YYYY.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: In case of a planned study, it is the intended start date; in case of an ongoing study — the actual start date.
Value Domain | Date
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept studyStartDate in dataset Core Metadata Schema (V3.3)
studyEndDate |
Id | (2022‑11‑28)
Synonym | study_end_date
Description | End date of data collection for the study
### Properties
No 3_0 | 1.17.14
Rationale | Description: In case of studies with patients or other participants, it is the date when the last participant is examined or receives an intervention, or the date of the last participant’s last visit. Additional information: Preferred date format: DD.MM.YYYY.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: In case of a planned or ongoing study, it is the intended end date; in case of a completed study — the actual end date.
Value Domain | Date
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept studyEndDate in dataset Core Metadata Schema (V3.3)
countries |
Id | (2022‑11‑28)
Synonym | study_countries
Description | Country(ies) where the study takes place
### Properties
No 3_0 | 1.17.15
Rationale | Description: Country or countries where the study takes place.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description
Country names from the ISO 3166-1 list |
Value Set required http://hl7.org/fhir/ValueSet/country (version 2023‑08‑28 23:09:48)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept countries in dataset Core Metadata Schema (V3.3)
region |
Id | (2022‑11‑28)
Synonym | study_region
Description | Regions and/or cities within a country where the study takes place
### Properties
No 3_0 | 1.17.16
Rationale | Description: If applicable, region(s) and/or city(ies) within a country where the study takes place.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept region in dataset Core Metadata Schema (V3.3)
centers |
Id | (2022‑11‑28)
Synonym | study_centers
Description | Is it a mono- or multicentric study?
### Properties
No 3_0 | 1.17.17
Rationale | Description: Specification whether a study is conducted at one study center or at more than one study center.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Monocentric |  | code "084" (Monocentric) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Multicentric |  | code "255206009" (Multicentric (qualifier value)) from code system "SNOMED Clinical Terms"
Value Set required NFDI4Health_VS_MDS_Study_Centers_SNOMEDCT_Local (version 2023‑08‑28 23:15:07)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept centers in dataset Core Metadata Schema (V3.3)
centersNumber |
Id | (2022‑11‑28)
Synonym | study_centers_number
Description | Number of study centers
### Properties
No 3_0 | 1.17.18
Rationale | Description: Number of centers involved in the study.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1, if study_centers == "Multicentric"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Quantity
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept centersNumber in dataset Core Metadata Schema (V3.3)
subject |
Id | (2022‑11‑28)
Synonym | study_subject
Description | Primary study subject
### Properties
No 3_0 | 1.17.19
Rationale | Description: Primary study subject, i.e. a person, an animal or some other type of the subject.
Source | NFDI4Health DDI [ https://ddialliance.org/Specification/DDI-CV/AnalysisUnit_1.0.html]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Person | Any individual person, irrespective of demographic characteristics, professional, social or legal status, or affiliation [DDI (https://ddialliance.org/Specification/DDI-CV/AnalysisUnit_1.0.html)]. | code "125676002" (Person (person)) from code system "SNOMED Clinical Terms"
Animal | A non-human living organism that has membranous cell walls, requires oxygen and organic foods, and is capable of voluntary movement, as distinguished from a plant or mineral [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health]. | code "387961004" (Kingdom Animalia (organism)) from code system "SNOMED Clinical Terms"
Other | A study subject that is not covered by any of the other values in this list [NFDI4Health]. | code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
Unknown | The study subject is unknown [NFDI4Health]. | code "261665006" (Unknown (qualifier value)) from code system "SNOMED Clinical Terms"
Value Set required NFDI4Health_VS_MDS_Study_Subject_SNOMEDCT (version 2023‑08‑28 23:18:11)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept subject in dataset Core Metadata Schema (V3.3)
sampling | link
Id | (2022‑11‑28)
Synonym | study_sampling
Description | Sampling method
### Properties
No 3_0 | 1.17.20
Rationale | Description: Group of items providing information about the applied sampling method.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Operationalization | Short input help: Select one value from the list.
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept sampling in dataset Core Metadata Schema (V3.3)
method |
Id | (2022‑11‑28)
Synonym | study_sampling_method
Description | Applied sampling method
### Properties
No 3_0 | 1.17.20.1
Rationale | Description: Type of the sampling method applied for the selection of study participants.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DDI [ https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Probability | All units (individuals, households, organizations, etc.) of a target population have a non-zero probability of being included in the sample and this probability can be accurately determined. Use this broader term if a more specific type of probability sampling is not known or is difficult to identify [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "034" (Probability Sampling Method) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Non-probability | The selection of units (individuals, households, organizations, etc.) from the target population is not based on random selection. It is not possible to determine the probability of each element to be sampled. Use this broader term if the specific type of non-probability is not known, difficult to identify, or if multiple non-probability methods are being employed [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "160" (Non-probability) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Mixed probability and non-probability | Sample design that combines probability and non-probability sampling within the same sampling process. Different types of sampling may be used at different stages of creating the sample. For example, for a sample of minority students in a city, schools are randomly selected in the first stage. Then, a quota sample of students is selected within each school in the second stage. If separate samples are drawn from the same target population using different sampling methods, the type of sampling procedure used for each sample should be classified separately [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "035" (Mixed Probability and Non-Probability Sampling Method) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Total universe/Complete enumeration | All units (individuals, households, organizations, etc.) of a target population are included in the data collection. For example, if the target population is defined as the members of a trade union, all union members are invited to participate in the study. Also called "census" if the entire population of a regional unit (e.g. a country) is selected [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "036" (Total universe/Complete enumeration) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other | A sampling procedure that is not covered by any of the other values in this list [NFDI4Health]. | code "164" (Other (method)) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Unknown | The sampling procedure is unknown [NFDI4Health]. | code "165" (Unknown (method)) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Not applicable | The sampling procedure is not applicable [NFDI4Health]. | code "166" (Not applicable (method)) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set NFDI4Health_VS_MDS_Study_Sampling_Method_Local (version 2023‑10‑25 15:04:45)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept method in dataset Core Metadata Schema (V3.3)
probabilityMethod |
Id | (2022‑11‑28)
Synonym | study_sampling_method_probability
Description | Specific type of probability sampling
### Properties
No 3_0 | 1.17.20.2
Rationale | Description: Specific type of the probability sampling method applied for the selection of study participants.
Source | NFDI4Health DDI [ https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html]
Comment | Cardinality: 0..1, if study_sampling_method == "Probability"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: If known, select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Simple random | A probability-based method. All units of a target population have an equal probability of being included in the sample. Typically, the entire population is listed in a "sample frame", and units are then chosen from this frame using a random selection method [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "167" (Simple random) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Systematic random | A probability-based method. A fixed selection interval is determined by dividing the population size by the desired sample size. A starting point is then randomly drawn from the sample frame, which normally covers the entire target population. From this starting point, units for the sample are chosen based on the selection interval. Also known as interval sampling. For example, a company survey seeks a sample of 1,000 employees out of 10,000 total. Beginning with a random starting number, every 10th name from the employee list of the company will be invited to participate in the study [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "168" (Systematic random) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Stratified | A probability-based method. The target population is subdivided into separate and mutually exclusive segments (strata) that cover the entire population. Independent random samples are then drawn from each segment. For example, in a national public opinion survey the entire population is divided into two regional strata: East and West. After this, sampling units are drawn from within each region using simple or systematic random sampling. Use this broader term if the specific type of stratified sampling is not known or difficult to identify [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "169" (Stratified) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Stratified: Proportional | A probability-based method. The target population is subdivided into separate and mutually exclusive segments (strata) that cover the entire population. In proportional stratified sampling the number of elements chosen from each stratum is proportional to the population size of the stratum when viewed against the entire population. For example, a country is divided into two regional strata that comprise 80 percent (West) and 20 percent (East) of the total population. For a sample of 1,000 people, 800 (i.e., 80 percent) would be drawn from the West and 200 (i.e., 20 percent) from the East to accurately represent their proportion in the total population [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "170" (Stratified - Proportional) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Stratified: Disproportional | A probability-based method. The target population is subdivided into separate and mutually exclusive segments (strata) that cover the entire population. In disproportional sampling the number of units chosen from each stratum is not proportional to the population size of the stratum when viewed against the entire population. The number of sampled units from each stratum can be equal, optimal, or can reflect the purpose of the study, like oversampling of different subgroups of the population. For example, a country is divided into two regional strata that comprise 80 percent (West) and 20 precent (East) of the country's population. If equal representation of the two regions is needed in a study, half the sample may be drawn from the West and half from the East, so that each region is represented by 50 percent of the sample. If a more detailed analysis of the population from the East is needed, 40 percent of the units may be drawn from the West and 60 percent from the East, so that the East is over-represented [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "171" (Stratified - Disproportional) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Cluster | A probability-based method. The target population is divided into naturally occurring segments (clusters) and a probability sample of the clusters is selected. Data are then collected from all units within each selected cluster. Sampling is often clustered by geography, or time period. Use this broader term if a more specific type of cluster sampling is not known or is difficult to identify [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "126" (Cluster) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Cluster: Simple random | A probability-based method. The target population is divided into naturally occurring segments (clusters) and a simple random sample of the clusters is selected. Data are then collected from all units within each selected cluster. For example, for a sample of students in a city, a number of schools would be chosen using the random selection method, and then all of the students from every sampled school would be included [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "127" (Cluster - Simple random) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Cluster: Stratified random | A probability-based method. The target population is divided into naturally occurring segments (clusters); next, these are divided into mutually exclusive strata and a random sample of clusters is selected from each stratum. Data are then collected from all units within each selected cluster. For example, for a sample of students in a city, schools would be divided into two strata by school type (private vs. public); schools would be then randomly selected from each stratum, and all of the students from every sampled school would be included [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "128" (Cluster - Stratified random) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Multistage | A probability-based method. Sampling is carried out in stages using smaller and smaller units at each stage, and all stages involve a probability selection. The type of probability sampling procedure may be different at each stage. For example, for a sample of students in a city, schools are randomly selected in the first stage. A random sample of classes within each selected school is drawn in the second stage. Students are then randomly selected from each of these classes in the third stage [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "172" (Multistage) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set required NFDI4Health_VS_MDS_Study_Sampling_Probability_Method_Local (version 2023‑10‑26 12:59:31)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept probabilityMethod in dataset Core Metadata Schema (V3.3)
nonProbabilityMethod |
Id | (2022‑11‑28)
Synonym | study_sampling_method_non_probability
Description | Specific type of non-probability sampling
### Properties
No 3_0 | 1.17.20.3
Rationale | Description: Specific type of the probability sampling method applied for the selection of study participants.
Source | NFDI4Health DDI [ https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html]
Comment | Cardinality: 0..1, if study_sampling_method == "Non-probability"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: If known, select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Quota | A non-probability-based method. The target population is subdivided into separate and mutually exclusive segments according to some predefined quotation criteria. The distribution of the quotation criteria (gender/age/ethnicity ratio, or other characteristics, like religion, education, etc.) is intended to reflect the real structure of the target population or the structure of the desired study population. Non-probability samples are then drawn from each segment until a specific number of units has been reached. For example, if the target population consists of 45 percent females and 55 percent males, a proportional quota sample will have the same gender percentages, while in a non-proportional quota sample the percentages will be different, based on some study-related consideration (for instance, the need to oversample for certain under-represented segments of the population) [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "177" (Quota) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Respondent-assisted | A non-probability-based method. Sample units are identified from a target population with the assistance of units already selected (adapted from "Public Health Research Methods", ed. Greg Guest, Emily E. Namey, 2014). A typical case is snowball sampling, in which the researcher identifies a group of units that matches a particular criterion of eligibility. The latter are asked to recruit other members of the same population that fulfil the same criterion of eligibility (sampling of specific populations like migrants, etc.) [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "008" (Respondent-assisted) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Purposive | A non-probability-based method. Sample units are specifically identified, selected and contacted for the information they can provide on the researched topic. Selection is based on different characteristics of the independent and/or dependent variables under study, and relies on the researchers' judgement. The study authors, or persons authorized by them have control over the sample selection mechanism and the universe is defined in terms of the selection criteria. Also called "judgement" sampling. For example, a medical researcher may intentionally select individuals who are similar in most respects, except on the outcome of the research topic, which can be a specific disease. Some types of purposive sampling are typical/deviant case, homogeneous/maximum variation, expert, or critical case sampling [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "174" (Purposive) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Availability | A non-probability-based method. The sample selection is based on the units' accessibility/relative ease of access. They may be easy to approach, or may themselves choose to participate in the study (self-selection). Researchers may have particular target groups in mind but they do not control the sample selection mechanism. For example, students leaving a particular building on campus may be approached, or individuals may volunteer to participate in response to invitations that do not target them specifically, but a larger group to which they may belong. Also called "convenience" or "opportunity" sampling [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. |
Value Set required NFDI4Health_VS_MDS_Study_Sampling_Method_Non_Probability_Local (version 2023‑10‑26 13:15:19)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept nonProbabilityMethod in dataset Core Metadata Schema (V3.3)
dataSource | link
Id | (2022‑11‑28)
Synonym | study_data_source
Description | Data sources from which study data are generated or extracted.
### Properties
No 3_0 | 1.17.21
Rationale | Description: Group of items providing information about data sources from which study data are generated or extracted.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept dataSource in dataset Core Metadata Schema (V3.3)
general |
Id | (2022‑11‑28)
Synonym | study_data_sources_general
Description | Data sources for the study (e.g. biosamples, registries, questionnaires, etc.)
### Properties
No 3_0 | 1.17.21.1
Rationale | Description: Different types of data sources from which study data are generated or extracted.
Source | NFDI4Health MIABIS [ https://github.com/BBMRI-ERIC/miabis] Maelstrom [doi: 10.1371/journal.pone.0200926]
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Biological samples |  | code "C2347026" (Biospecimen (Body Substance)) from code system "Unified Medical Language System"
Administrative databases |  | code "028" (Administrative databases) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Cognitive measurements |  | code "029" (Cognitive measurements) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Genealogical records |  | code "030" (Genealogical records) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Imaging data |  | code "031" (Imaging data) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Medical records |  | code "C025102" (Medical Records (Intellectual Product)) from code system "Unified Medical Language System"
Registries |  | code "C0034875" (Registries (Intellectual Product)) from code system "Unified Medical Language System"
Interview |  | code "C0021822" (Interview (Activity)) from code system "Unified Medical Language System"
Questionnaire |  | code "C0034394" (Questionnaires (Intellectual Product)) from code system "Unified Medical Language System"
Physiological/Biochemical measurements |  | code "032" (Physiological/Biochemical measurements) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Omics technology |  | code "033" (Omics technology) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other |  | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Study_Data_Sources_General_UMLS_Local (version 2023‑08‑28 23:51:16)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept general in dataset Core Metadata Schema (V3.3)
biosamples |
Id | (2022‑11‑28)
Synonym | study_data_sources_biosamples
Description | Biosamples collected in the study
### Properties
No 3_0 | 1.17.21.2
Rationale | Description: Specification of biosamples collected in the study.
Source | NFDI4Health MIABIS [ https://github.com/BBMRI-ERIC/miabis] Maelstrom [doi: 10.1371/journal.pone.0200926]
Comment | Cardinality: 0..*, if study_data_source_general == "Biological samples"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Blood |  | code "87612001" (Blood (substance)) from code system "SNOMED Clinical Terms"
Buccal cells |  | code "C172264" (Buccal Cell Sample (Cell)) from code system "NCI Metathesaurus"
Cord blood |  | code "12499000" (Cord blood (substance)) from code system "SNOMED Clinical Terms"
DNA |  | code "24851008" (Deoxyribonucleic acid (substance)) from code system "SNOMED Clinical Terms"
Faeces |  | code "39477002" (Feces (substance)) from code system "SNOMED Clinical Terms"
Hair |  | code "395508003" (Hair - material (substance)) from code system "SNOMED Clinical Terms"
Immortalized cell lines |  | code "C0178708" (immortalized cell (Cell)) from code system "Unified Medical Language System"
Isolated pathogen |  | code "C80324" (Pathogen (Conceptual Entity)) from code system "NCI Metathesaurus"
Nail |  | code "119327009" (Nail specimen (specimen)) from code system "SNOMED Clinical Terms"
Plasma |  | code "50863008" (Plasma (substance)) from code system "SNOMED Clinical Terms"
RNA |  | code "27888000" (Ribonucleic acid (substance)) from code system "SNOMED Clinical Terms"
Saliva |  | code "256897009" (Saliva (substance)) from code system "SNOMED Clinical Terms"
Serum |  | code "67922002" (Serum (substance)) from code system "SNOMED Clinical Terms"
Tissue (frozen) |  | code "16214131000119104" (Frozen tissue section specimen (specimen)) from code system "SNOMED Clinical Terms"
Tissue (FFPE) |  | code "441652008" (Formalin-fixed paraffin-embedded tissue specimen (specimen)) from code system "SNOMED Clinical Terms"
Urine |  | code "78014005" (Urine (substance)) from code system "SNOMED Clinical Terms"
Other biological samples |  | code "C17649" (Other (Qualitative Concept)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Study_DS_Biosamples_SNOMEDCT_NCI_UMLS (version 2023‑08‑28 23:58:22)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept biosamples in dataset Core Metadata Schema (V3.3)
imaging |
Id | (2022‑11‑28)
Synonym | study_data_sources_imaging
Description | Imaging data collected in the study
### Properties
No 3_0 | 1.17.21.3
Rationale | Description: Specification of imaging data collected in the study.
Source | NFDI4Health MIABIS [ https://github.com/BBMRI-ERIC/miabis] Maelstrom [doi: 10.1371/journal.pone.0200926]
Comment | Cardinality: 0..*, if study_data_source_general == "Imaging data"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Ultrasound |  | code "C115503" (Ultrasound Study File (Manufactured Object)) from code system "NCI Metathesaurus"
Magnetic resonance imaging (MRI) |  | code "C115501" (Magnetic Resonance Imaging Study File (Manufactured Object)) from code system "NCI Metathesaurus"
Radiography (x-ray) |  | code "C115721" (Radiography Study File (Intellectual Product)) from code system "NCI Metathesaurus"
Computed tomography (CT) |  | code "C115499" (Computed Tomography Study File (Manufactured Object)) from code system "NCI Metathesaurus"
Other imaging data |  | code "C115545" (Medical Imaging File Not Otherwise Specified (Intellectual Product)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Study_Data_Sources_Imaging_NCI (version 2023‑08‑29 00:03:51)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept imaging in dataset Core Metadata Schema (V3.3)
omics |
Id | (2022‑11‑28)
Synonym | study_data_sources_omics
Description | Omics technology used in the study
### Properties
No 3_0 | 1.17.21.4
Rationale | Description: Specification of omics technology applied in the study.
Source | NFDI4Health MIABIS [ https://github.com/BBMRI-ERIC/miabis] Maelstrom [doi: 10.1371/journal.pone.0200]
Comment | Cardinality: 0..*, if study_data_source_general == "Omics technology"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Biomarkers |  | code "C63333" (Biomarker Analysis) from code system "NCI Metathesaurus"
Genomics |  | code "C84343" (Genomics) from code system "NCI Metathesaurus"
Metabolomics |  | code "C49019" (Metabolomics) from code system "NCI Metathesaurus"
Transcriptomics |  | code "C153189" (Transcriptomics) from code system "NCI Metathesaurus"
Proteomics |  | code "C20085" (Proteomics) from code system "NCI Metathesaurus"
Other omics technology |  | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Study_Data_Sources_Omics_NCI_UMLS (version 2023‑08‑29 00:08:26)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept omics in dataset Core Metadata Schema (V3.3)
description |
Id | (2022‑11‑28)
Synonym | study_data_source_description
Description | Additional information about data sources
### Properties
No 3_0 | 1.17.21.5
Rationale | Description: If needed, additional descriptive information about study data sources, e.g. indication of the data source(s) not listed in the property „Data sources for the study” or more detailed description of the selected data sources.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: E.g., indication of the data source(s) not listed in the field „Data sources for the study” or more detailed description of the selected data sources.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept description in dataset Core Metadata Schema (V3.3)
primaryPurpose |
Id | (2022‑11‑28)
Synonym | study_primary_purpose
Description | Primary purpose of the study
### Properties
No 3_0 | 1.17.22
Rationale | Description: Specification of the main purpose of the study. Additional information: The field is defined foremost for interventional studies. For non-interventional studies, this field may be not appplicable as diverse purposes may be pursued without being able to specify a primary one. In this case, the option "Not applicable" can be selected.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Foremost for interventional studies, please specify the primary purpose why the study was conducted. For non-interventional studies, this field may be "Not appplicable" as multiple purposes may be defined as primary ones.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Treatment | One or more interventions are being evaluated for treating a disease, syndrome, or condition [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "treatment" (Treatment) from code system "ResearchStudyPrimaryPurposeType"
Prevention | One or more interventions are being assessed for preventing the development of a specific disease or health condition [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "prevention" (Prevention) from code system "ResearchStudyPrimaryPurposeType"
Prognostic | One or more interventions are being evaluated for making a prediction of the course of the disease [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health]. | code "C0220901" (prognostic (Intellectual Product)) from code system "Unified Medical Language System"
Diagnostic | One or more interventions are being evaluated for identifying a disease or health condition [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "diagnostic" (Diagnostic) from code system "ResearchStudyPrimaryPurposeType"
Supportive care | One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "supportive-care" (Supportive Care) from code system "ResearchStudyPrimaryPurposeType"
Screening | One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "screening" (Screening) from code system "ResearchStudyPrimaryPurposeType"
Health services research | One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "health-services-research" (Health Services Research) from code system "ResearchStudyPrimaryPurposeType"
Basic science/Physiological study | One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention) [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "basic-science" (Basic Science) from code system "ResearchStudyPrimaryPurposeType"
Device feasibility | An intervention of a device product is being evaluated in a small clinical trial (generally fewer than 10 participants) to determine the feasibility of the product; or a clinical trial to test a prototype device for feasibility and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "device-feasibility" (Device Feasibility) from code system "ResearchStudyPrimaryPurposeType"
Pharmacogenetics | The investigation of the influence of variations in DNA sequence on drug response [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C129001 " (Pharmacogenetic Study) from code system "NCI Metathesaurus"
Pharmacogenomics | The influence of genotype on drug response, for example by correlating gene expression or single-nucleotide polymorphisms with drug efficacy or toxicity [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C1709519" (Pharmacogenomic Study (Research Activity)) from code system "Unified Medical Language System"
Health economics | Economic aspects of the field of medicine, the medical profession, and health care. It includes the economic and financial impact of disease in general on the patient, the physician, society, or government [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C5241252" (Health Economics (Occupational Activity)) from code system "Unified Medical Language System"
Not applicable | A primary study purpose can not be applied [NFDI4Health]. | code "C1272460" (Not Applicable (Qualitative Concept)) from code system "Unified Medical Language System"
Other | A purpose that is not covered by any of the other values in this list [NFDI4Health]. | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Study_Primary_Purpose_UMLS_NCI (version 2023‑08‑29 00:15:04)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept primaryPurpose in dataset Core Metadata Schema (V3.3)
eligibilityCriteria | link
Id | (2022‑11‑28)
Synonym | study_eligibility_criteria
Description | Eligibility criteria for study participants
### Properties
No 3_0 | 1.17.23
Rationale | Description: Group of items providing information about eligibility criteria for study participants.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept eligibilityCriteria in dataset Core Metadata Schema (V3.3)
ageMin | link
Id | (2022‑11‑28)
Synonym | study_eligibility_age_min
Description | Eligibility criteria: Minimum age
### Properties
No 3_0 | 1.17.23.1
Rationale | Description: Group of items providing information about the minimum eligible age of study participants.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept ageMin in dataset Core Metadata Schema (V3.3)
number |
Id | (2022‑11‑28)
Synonym | number
Description | Minimum eligible age
### Properties
No 3_0 | 1.17.23.1.1
Rationale | Description: Numerical value of the minimum age of potential participants eligible to participate in the study.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Quantity
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept number in dataset Core Metadata Schema (V3.3)
timeUnit |
Id | (2022‑11‑28)
Synonym | time_unit
Description | Unit of time
### Properties
No 3_0 | 1.17.23.1.2
Rationale | Description: Unit of time.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Years |  | code "a" (year) from code system "UCUM"
Months |  | code "mo" (month) from code system "UCUM"
Weeks |  | code "we" (week) from code system "UCUM"
Days |  | code "d" (day) from code system "UCUM"
Hours |  | code "h" (hour) from code system "UCUM"
Minutes |  | code "min" (minute) from code system "UCUM"
Weeks of gestation |  | code "C1135241" (Weeks pregnant (Finding)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Time_Units_UCUM_UMLS (version 2023‑08‑29 00:22:33)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept timeUnit in dataset Core Metadata Schema (V3.3)
ageMax | link
Id | (2022‑11‑28)
Synonym | study_eligibility_age_max
Description | Eligibility criteria: Maximum age
### Properties
No 3_0 | 1.17.23.2
Rationale | Description: Group of items providing information about the maximum eligible age of study participants.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept ageMax in dataset Core Metadata Schema (V3.3)
number |
Id | (2022‑11‑28)
Synonym | number
Description | Maximum eligible age
### Properties
No 3_0 | 1.17.23.2.1
Rationale | Description: Numerical value of the maximum age of potential participants eligible to participate in the study.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Quantity
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept number in dataset Core Metadata Schema (V3.3)
timeUnit |
Id | (2022‑11‑28)
Synonym | time_unit
Description | Unit of time
### Properties
No 3_0 | 1.17.23.2.2
Rationale | Description: Unit of time.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Years |  | code "a" (year) from code system "UCUM"
Months |  | code "mo" (month) from code system "UCUM"
Weeks |  | code "we" (week) from code system "UCUM"
Days |  | code "d" (day) from code system "UCUM"
Hours |  | code "h" (hour) from code system "UCUM"
Minutes |  | code "min" (minute) from code system "UCUM"
Weeks of gestation |  | code "C1135241" (Weeks pregnant (Finding)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Time_Units_UCUM_UMLS (version 2023‑08‑29 00:22:33)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept timeUnit in dataset Core Metadata Schema (V3.3)
genders |
Id | (2022‑11‑28)
Synonym | study_eligibility_genders
Description | Eligible gender
### Properties
No 3_0 | 1.17.23.3
Rationale | Description: Gender of potential participants eligible to participate in the study.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Male |  | code "248153007" (Male) from code system "http://hl7.org/fhir/administrative-gender"
Female |  | code "248152002" (Female) from code system "http://hl7.org/fhir/administrative-gender"
Diverse |  | code "105" (Diverse) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Not applicable |  | code "385432009" (Not applicable) from code system "http://hl7.org/fhir/administrative-gender"
Value Set NFDI4Health_VS_MDS_Study_Eligibility_Gender_SNOMEDCT_Local (version 2023‑08‑29 14:35:27)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept genders in dataset Core Metadata Schema (V3.3)
inclusionCriteria |
Id | (2022‑11‑28)
Synonym | study_eligibility_inclusion_criteria
Description | Inclusion criteria
### Properties
No 3_0 | 1.17.23.4
Rationale | Description: Inclusion criteria for participation in the study.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: If possible, use an enumerated or bulleted list for each criterion.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept inclusionCriteria in dataset Core Metadata Schema (V3.3)
exclusionCriteria |
Id | (2022‑11‑28)
Synonym | study_eligibility_exclusion_criteria
Description | Exclusion criteria
### Properties
No 3_0 | 1.17.23.5
Rationale | Description: Exclusion criteria for participation in the study.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: If possible, use an enumerated or bulleted list for each criterion.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept exclusionCriteria in dataset Core Metadata Schema (V3.3)
population |
Id | (2022‑11‑28)
Synonym | study_population
Description | Description of study population
### Properties
No 3_0 | 1.17.24
Rationale | Description: Additional descriptive information providing more details about study population.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] Maelstrom [doi: 10.1371/journal.pone.0200926]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Any information important for the given study population can be specified here.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept population in dataset Core Metadata Schema (V3.3)
targetSampleSize |
Id | (2022‑11‑28)
Synonym | study_target_sample_size
Description | Target sample size
### Properties
No 3_0 | 1.17.25
Rationale | Description: Intended number of observational units for the whole study (e.g. intended number of study participants at all study sites).
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Enter “-1” if target sample size was not set or is unknown.
Value Domain | Quantity
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept targetSampleSize in dataset Core Metadata Schema (V3.3)
obtainedSampleSize |
Id | (2022‑11‑28)
Synonym | study_obtained_sample_size
Description | Obtained sample size
### Properties
No 3_0 | 1.17.26
Rationale | Description: Obtained number of observational units for the whole study (e.g. obtained number of study participants at all study sites). The value is only available after the end of recruitment.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Enter “-1” if obtained sample size is unknown.
Value Domain | Quantity
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept obtainedSampleSize in dataset Core Metadata Schema (V3.3)
ageMinExamined | link
Id | (2022‑11‑28)
Synonym | study_age_min_examined
Description | Actual minimum age of participants
### Properties
No 3_0 | 1.17.27
Rationale | Description: Group of items providing information about the actual minimum age of study participants at the time of examination.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Used by | 0 transactions, 0 templates, inherited 2 times
| This concept is inherited by concept ageMinExamined in dataset Core Metadata Schema (V3.3) This concept is inherited by concept ageMinExamined in dataset Module Design (V3.3) (v3.3)
number |
Id | (2022‑11‑28)
Synonym | number
Description | Actual minimum age of participants
### Properties
No 3_0 | 1.17.27.1
Rationale | Description: Numerical value of the minimum age of study participants at the time of examination.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Quantity
Used by | 0 transactions, 0 templates, inherited 2 times
| This concept is inherited by concept number in dataset Core Metadata Schema (V3.3) This concept is inherited by concept number in dataset Module Design (V3.3) (v3.3)
timeUnit |
Id | (2022‑11‑28)
Synonym | time_unit
Description | Unit of time
### Properties
No 3_0 | 1.17.27.2
Rationale | Description: Unit of time.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Years |  | code "a" (year) from code system "UCUM"
Months |  | code "mo" (month) from code system "UCUM"
Weeks |  | code "we" (week) from code system "UCUM"
Days |  | code "d" (day) from code system "UCUM"
Hours |  | code "h" (hour) from code system "UCUM"
Minutes |  | code "min" (minute) from code system "UCUM"
Weeks of gestation |  | code "C1135241" (Weeks pregnant (Finding)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Time_Units_UCUM_UMLS (version 2023‑08‑29 00:22:33)
Used by | 0 transactions, 0 templates, inherited 2 times
| This concept is inherited by concept timeUnit in dataset Core Metadata Schema (V3.3) This concept is inherited by concept timeUnit in dataset Module Design (V3.3) (v3.3)
ageMaxExamined | link
Id | (2022‑11‑28)
Synonym | study_age_max_examined
Description | Actual maximum age of participants
### Properties
No 3_0 | 1.17.28
Rationale | Description: Group of items providing information about the actual maximum age of study participants at the time of examination.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Used by | 0 transactions, 0 templates, inherited 2 times
| This concept is inherited by concept ageMaxExamined in dataset Core Metadata Schema (V3.3) This concept is inherited by concept ageMaxExamined in dataset Module Design (V3.3) (v3.3)
number |
Id | (2022‑11‑28)
Synonym | number
Description | Actual maximum age of participants
### Properties
No 3_0 | 1.17.28.1
Rationale | Description: Numerical value of the maximum age of study participants at the time of examination.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Quantity
Used by | 0 transactions, 0 templates, inherited 2 times
| This concept is inherited by concept number in dataset Core Metadata Schema (V3.3) This concept is inherited by concept number in dataset Module Design (V3.3) (v3.3)
timeUnit |
Id | (2022‑11‑28)
Synonym | time_unit
Description | Unit of time
### Properties
No 3_0 | 1.17.28.2
Rationale | Description: Unit of time.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Years |  | code "a" (year) from code system "UCUM"
Months |  | code "mo" (month) from code system "UCUM"
Weeks |  | code "we" (week) from code system "UCUM"
Days |  | code "d" (day) from code system "UCUM"
Hours |  | code "h" (hour) from code system "UCUM"
Minutes |  | code "min" (minute) from code system "UCUM"
Weeks of gestation |  | code "C1135241" (Weeks pregnant (Finding)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Time_Units_UCUM_UMLS (version 2023‑08‑29 00:22:33)
Used by | 0 transactions, 0 templates, inherited 2 times
| This concept is inherited by concept timeUnit in dataset Core Metadata Schema (V3.3) This concept is inherited by concept timeUnit in dataset Module Design (V3.3) (v3.3)
hypothesis |
Id | (2022‑11‑28)
Synonym | study_hypothesis
Description | Research questions and/or hypothesis underlying the study
### Properties
No 3_0 | 1.17.29
Rationale | Description: Statement of the research questions and/or hypotheses underlying the study.
Source | NFDI4Health ISRCTN [ https://www.isrctn.com/]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept hypothesis in dataset Core Metadata Schema (V3.3)
armsGroups | link
Id | (2022‑11‑28)
Synonym | study_arms_groups
Description | Arms or groups/cohorts of the study
### Properties
No 3_0 | 1.17.30
Rationale | Description: Group of items providing information about arms or groups/cohorts of the study.
Source | NFDI4Health
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept armsGroups in dataset Core Metadata Schema (V3.3)
label |
Id | (2022‑11‑28)
Synonym | study_arm_group_label
Description | Name of the arm/group
### Properties
No 3_0 | 1.17.30.1
Rationale | Description: Short name used to identify the arm/group. Additional information: For interventional studies: "Arm" means a pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol. For non-interventional studies: "Group" means a predefined group (cohort) of participants to be studied.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept label in dataset Core Metadata Schema (V3.3)
type |
Id | (2022‑11‑28)
Synonym | study_arm_group_type
Description | Role of the arm
### Properties
No 3_0 | 1.17.30.2
Rationale | Description: Role of the given arm in the study.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 1..1, if study_primary_design =="Interventional"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Experimental | An arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C5420675" (Investigational Arm (Research Study)) from code system "Unified Medical Language System"
Active comparator | An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C2347177" (Active Comparator (Conceptual Entity)) from code system "Unified Medical Language System"
Placebo comparator | An arm type in which a group of participants receives a placebo during a clinical trial [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C5420677" (Placebo Control Arm (Research Activity)) from code system "Unified Medical Language System"
Sham comparator | An arm type in which a group of participants receives a procedure or device that appears to be the same as the actual procedure or device being studied but does not contain active processes or components [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C5420678" (Sham Comparator Arm (Research Activity)) from code system "Unified Medical Language System"
No intervention | An arm type in which a group of participants does not receive any intervention/treatment during the clinical trial [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C5420679" (No Intervention Arm (Research Activity)) from code system "Unified Medical Language System"
Other | A type of the study arm that is not covered by any of the other values in this list [NFDI4Health]. | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Study_Arm_Group_Type_UMLS (version 2023‑08‑29 14:45:20)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept type in dataset Core Metadata Schema (V3.3)
description |
Id | (2022‑11‑28)
Synonym | study_arm_group_description
Description | Additional information about the arm/group
### Properties
No 3_0 | 1.17.30.3
Rationale | Description: Additional descriptive information about the given arm/group. Additional information: For interventional studies: If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. For non-interventional studies: Explanation of the nature of the study group (for example, those with a condition and those without a condition; those with an exposure and those without an exposure).
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept description in dataset Core Metadata Schema (V3.3)
interventions | link
Id | (2022‑11‑28)
Synonym | study_interventions
Description | Interventions/exposures of the study
### Properties
No 3_0 | 1.17.31
Rationale | Description: Group of items providing information about study interventions or exposures. Additional information: The items may be not applicable for non-interventional studies.
Source | NFDI4Health
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept interventions in dataset Core Metadata Schema (V3.3)
name |
Id | (2022‑11‑28)
Synonym | study_intervention_name
Description | Name of the intervention/exposure
### Properties
No 3_0 | 1.17.31.1
Rationale | Description: A short descriptive name of the intervention/exposure. Additional information: Please specify the intervention(s)/exposure associated with each arm/group.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: If the same intervention/exposure is associated with more than one arm or group, provide the information once and use the field "Name of the associated study arm/group" to associate it with more than one arm/group.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept name in dataset Core Metadata Schema (V3.3)
type |
Id | (2022‑11‑28)
Synonym | study_intervention_type
Description | Type of the intervention/exposure
### Properties
No 3_0 | 1.17.31.2
Rationale | Description: General type of the given intervention/exposure.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Drug (including placebo) |  | code "C1909" (Pharmacologic Substance (Pharmacologic Substance)) from code system "NCI Metathesaurus"
Device (including sham) |  | code "C62103" (Device (Manufactured Object)) from code system "NCI Metathesaurus"
Biological/Vaccine |  | code "C0729513" (Vaccine and biological substance (Pharmacologic Substance)) from code system "Unified Medical Language System"
Procedure/Surgery |  | code "C79751" (Procedure (Activity)) from code system "NCI Metathesaurus"
Radiation |  | code "C61398" (Radiation Exposure (Phenomenon or Process)) from code system "NCI Metathesaurus"
Behavioral (e.g., psychotherapy, lifestyle counseling) |  | code "C15184" (Behavioral Intervention (Therapeutic or Preventive Procedure)) from code system "NCI Metathesaurus"
Genetic (including gene transfer, stem cell and recombinant DNA) |  | code "C17938" (Genetic (Functional Concept)) from code system "NCI Metathesaurus"
Dietary supplement (e.g., vitamins, minerals) |  | code "C1505" (Dietary Supplement (Food)) from code system "NCI Metathesaurus"
Combination product (combining a drug and device, a biological product and device; a drug and biological product; or a drug, biological product, and device) |  | code "C54696" (Combination Product (Manufactured Object)) from code system "NCI Metathesaurus"
Diagnostic test (e.g., imaging, in-vitro) |  | code "C17454" (Diagnostic Test (Diagnostic Procedure)) from code system "NCI Metathesaurus"
Other |  | code "C17649" (Other (Qualitative Concept)) from code system "NCI Metathesaurus"
Value Set NFDI4Health_VS_MDS_Study_Intervention_Type_NCI_UMLS (version 2023‑08‑29 14:51:08)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept type in dataset Core Metadata Schema (V3.3)
description |
Id | (2022‑11‑28)
Synonym | study_intervention_description
Description | Additional information about the intervention/exposure
### Properties
No 3_0 | 1.17.31.3
Rationale | Description: If needed, additional descriptive information about the given intervention/exposure.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept description in dataset Core Metadata Schema (V3.3)
armsGroupsLabel |
Id | (2022‑11‑28)
Synonym | study_intervention_arms_groups_label
Description | Name of the arm/group associated with the given intervention
### Properties
No 3_0 | 1.17.31.4
Rationale | Description: Name of the study arm associated with the given intervention.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept armsGroupsLabel in dataset Core Metadata Schema (V3.3)
studyOutcomes | link
Id | (2022‑11‑28)
Synonym | study_outcomes
Description | Outcome measure(s)
### Properties
No 3_0 | 1.17.32
Rationale | Description: Group of items providing information about outcome measure(s). Additional information: The items are optional for non-interventional studies.
Source | NFDI4Health
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept studyOutcomes in dataset Core Metadata Schema (V3.3)
type |
Id | (2022‑11‑28)
Synonym | study_outcome_type
Description | Type of the outcome measure
### Properties
No 3_0 | 1.17.32.1
Rationale | Description: Type of the outcome measure.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1, if (study_outcome_title != Null OR study_outcome_description != Null); otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Primary or secondary outcome measure?
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Primary | (1) The primary measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. These are the outcome measures used to assess the primary objective(s); (2) In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C3274433" (Primary Outcome Measure (Qualitative Concept)) from code system "Unified Medical Language System"
Secondary | (1) Other key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. These are the outcome measures used to assess the secondary objective(s); (2) In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C3274440" (Secondary Outcome Measure (Qualitative Concept)) from code system "Unified Medical Language System"
Other | Any other measurements, excluding post-hoc measures, that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Study_Outcome_Type_UMLS (version 2023‑08‑29 14:56:55)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept type in dataset Core Metadata Schema (V3.3)
title |
Id | (2022‑11‑28)
Synonym | study_outcome_title
Description | Name of the outcome measure
### Properties
No 3_0 | 1.17.32.2
Rationale | Description: Name of the outcome measure. For non-interventional studies, this can be the name of specific measurement(s) or observation(s) used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: For non-interventional studies, this can be specific measurement(s) or observation(s) used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept title in dataset Core Metadata Schema (V3.3)
description |
Id | (2022‑11‑28)
Synonym | study_outcome_description
Description | Description of the outcome measure
### Properties
No 3_0 | 1.17.32.3
Rationale | Description: Additional descriptive information about the given outcome
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept description in dataset Core Metadata Schema (V3.3)
timeFrame |
Id | (2022‑11‑28)
Synonym | study_outcome_time_frame
Description | Time point(s) of assessment
### Properties
No 3_0 | 1.17.32.4
Rationale | Description: Description of the time point(s) at which the measurement for the outcome is assessed, e.g. the specific duration of time over which each participant is assessed.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept timeFrame in dataset Core Metadata Schema (V3.3)
comment |
Id | (2022‑11‑28)
Synonym | study_design_comment
Description | Any additional information about the study
### Properties
No 3_0 | 1.17.33
Rationale | Description: Any additional information about specific aspects of the study that cannot be captured by other properties.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Any additional information about specific aspects of the study that cannot be captured by other properties.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept comment in dataset Core Metadata Schema (V3.3)
assessments |
Id | (2022‑11‑28)
Synonym | study_assessments
Description | Further assessments/measurements included in the study
### Properties
No 3_0 | 1.17.34
Rationale | Description: Assessments/measurements included in the study
Source | NFDI4Health ENPADASI [ https://academic.oup.com/jn/article/148/2/285/4913031]
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Diet/Nutrition | Information about the consumption of food (e.g. type, quantity and frequency of food intake) and associated behaviours. Also see Dom. 7 'Medication and supplements', under 'Medication and supplement intake' for information about the consumption of vitamins and supplements [Maelstrom (doi: 10.1371/journal.pone.0200926)]. | code "C1511900" (Diet and nutrition (Research Activity)) from code system "Unified Medical Language System"
Physical activity | Information about the type, frequency and intensity of physical activity such as exercises and sports (e.g. jogging, playing hockey), daily activities (e.g. household chores, walking the dog) or sedentarity (e.g. lounging on the couch) [Maelstrom (doi: 10.1371/journal.pone.0200926)]. | code "398636004" (Physical activity assessment (procedure)) from code system "SNOMED Clinical Terms"
Tobacco use | Information about the consumption of tobacco in any form (e.g. quantity and frequency of smoking, chewing or sniffing) and associated behaviors [Maelstrom (doi: 10.1371/journal.pone.0200926)]. | code "711013002" (Assessment of tobacco use (procedure)) from code system "SNOMED Clinical Terms"
Alcohol consumption | Information about the consumption of alcoholic beverages (e.g. frequency, quantity and type of alcohol consumed) and associated behaviors [Maelstrom (doi: 10.1371/journal.pone.0200926)]. | code "713127001" (Assessment of alcohol use (procedure)) from code system "SNOMED Clinical Terms"
Body weight | The weight of a subject [NCIT (https://github.com/NCI-Thesaurus/thesaurus-obo-edition)]. | code "39857003" (Weighing patient (procedure)) from code system "SNOMED Clinical Terms"
Body height | The distance from the base to the top of a subject's entire body [NIH Dietary Assessment Primer (https://dietassessmentprimer.cancer.gov/profiles/)]. | code "14456009" (Measuring height of patient (procedure)) from code system "SNOMED Clinical Terms"
Waist circumference | A circumferential measurement of the waist, which may be classified as the area immediately below the lowest rib, at the narrowest part of the torso, midpoint between the lowest rib and the iliac crest, or immediately above the iliac crest [NCIT (https://github.com/NCI-Thesaurus/thesaurus-obo-edition)]. | code "445396007" (Measurement of circumference of waist (procedure)) from code system "SNOMED Clinical Terms"
Body Mass Index | An individual's weight in kilograms divided by the square of the height in meters [NCIT (https://github.com/NCI-Thesaurus/thesaurus-obo-edition)]. | code "698094009" (Measurement of body mass index (procedure)) from code system "SNOMED Clinical Terms"
Body fat percentage | The amount of an individual's total body mass that is fat, expressed as a percent [NCIT (https://github.com/NCI-Thesaurus/thesaurus-obo-edition)]. | code "1230136007" (Method for determining body fat percentage (observable entity)) from code system "SNOMED Clinical Terms"
Sociodemographic information | Information about socio-demographic and economic characteristics [Maelstrom (doi: 10.1371/journal.pone.0200926)]. | code "C5544537" (Sociodemographic Factors (Idea or Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Study_Assessments_SNOMEDCT_UMLS (version 2023‑08‑29 15:03:18)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept assessments in dataset Core Metadata Schema (V3.3)
dataSharingPlan | link
Id | (2022‑11‑28)
Synonym | study_data_sharing_plan
Description | Information about data sharing
### Properties
No 3_0 | 1.17.35
Rationale | Description: Group of items providing information about the data sharing strategy of the study.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept dataSharingPlan in dataset Core Metadata Schema (V3.3)
generally |
Id | (2022‑11‑28)
Synonym | study_data_sharing_plan_generally
Description | Is it planned to share the data?
### Properties
No 3_0 | 1.17.35.1
Rationale | Description: Indication whether there is a plan to make data collected in the study available. In case of studies with patients or other individuals, this refers to individual participant data (IPD).
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Yes, there is a plan to make data available |  | code "373066001" (Yes (qualifier value)) from code system "SNOMED Clinical Terms"
No, there is no plan to make data available |  | code "373067005" (No (qualifier value)) from code system "SNOMED Clinical Terms"
Undecided, it is not yet known if data will be made available |  | code "C150084" (Undecided (Intellectual Product)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Yes_No_Undecided_SNOMEDCT_NCI (version 2023‑08‑29 15:11:25)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept generally in dataset Core Metadata Schema (V3.3)
supportingInformation |
Id | (2022‑11‑28)
Synonym | study_data_sharing_plan_supporting_information
Description | Supporting documents available in addition to the data
### Properties
No 3_0 | 1.17.35.2
Rationale | Description: Supporting information/documents which will be made available in addition to the study data.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 0..*, if study_data_sharing_plan_generally == "Yes, there is a plan to make data available"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Data dictionary | A document describing the data, including metadata, and their meaning, usage, and relationship to other data [NFDI4Health]. |
Study protocol | The formal plan of an experiment or research activity, including the objective, rationale, design, materials and methods for the conduct of the study; intervention description, and method of data analysis [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C2348563" (Study Protocol (Intellectual Product)) from code system "SNOMED Clinical Terms"
Protocol amendment | A written description of a change(s) to, or formal clarification of, a protocol [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C4321383" (Protocol Amendment (Intellectual Product)) from code system "SNOMED Clinical Terms"
Statistical analysis plan | A document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C3889277" (Statistical Analysis Plan (Intellectual Product)) from code system "SNOMED Clinical Terms"
Analytic code | A document that contains a code that extracts, manages, and analyses data [NFDI4Health]. |
Informed consent form | A template of a document explaining all the relevant information to assist an individual in understanding the expectations and risks in making a decision about a procedure. This document is presented to and signed by the individual or guardian [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C0009797" (Consent Forms (Intellectual Product)) from code system "SNOMED Clinical Terms"
Clinical study report | A written description of a study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C4553084" (Clinical study report (Intellectual Product)) from code system "SNOMED Clinical Terms"
Manual of operations (SOP) | Detailed, written instructions to achieve uniformity of the performance of a specific function [EMA (European Medicines Agency - ICH: E 6 (R2): Guideline for good clinical practice - Step 5 (europa.eu))]. | code "C3889288" (Standard Operating Procedure List (Intellectual Product)) from code system "SNOMED Clinical Terms"
Case report form (template) | A printed, optical, or electronic document designed to record all of the clinical study-required information stipulated in the protocol to be reported to the sponsor on each clinical trial subject [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C1516308" (Case Report Form (Intellectual Product) ) from code system "SNOMED Clinical Terms"
Questionnaire (template) | Set of pre-determined questions presented to study participants [DDI (https://ddialliance.org/Specification/DDI-CV/TypeOfInstrument_1.1.html)]. | code "C0034394" (Questionnaires (Intellectual Product)) from code system "SNOMED Clinical Terms"
Code book | Pre-defined categorization scheme used for content coding, a data collection technique to transform qualitative data (textual, video, audio or still-image) originally produced for other purposes into quantitative data [DDI (https://ddialliance.org/Specification/DDI-CV/TypeOfInstrument_1.1.html)]. |
Other | A study document that is not covered by any of the other values in this list [NFDI4Health]. | code "C0205394" (Other (Qualitative Concept)) from code system "SNOMED Clinical Terms"
Value Set required NFDI4Health_VS_MDS_Study_Data_Sharing_Plan_Supporting_Information_UMLS_Local (version 2023‑08‑29 15:46:25)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept supportingInformation in dataset Core Metadata Schema (V3.3)
timeFrame |
Id | (2022‑11‑28)
Synonym | study_data_sharing_plan_time_frame
Description | When and for how long will the data be available?
### Properties
No 3_0 | 1.17.35.3
Rationale | Description: Indication when the data and, if applicable, supporting documents will become available and for how long.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 0..1, if study_data_sharing_plan_generally == "Yes, there is a plan to make data available"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept timeFrame in dataset Core Metadata Schema (V3.3)
accessCriteria |
Id | (2022‑11‑28)
Synonym | study_data_sharing_plan_access_criteria
Description | Criteria for the data access
### Properties
No 3_0 | 1.17.35.4
Rationale | Description: Indication by what access criteria data will be shared, including: a) with whom, b) for what types of analyses, and c) by what mechanism.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 0..1, if study_data_sharing_plan_generally == "Yes, there is a plan to make data available"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: E.g., with whom, for what types of analyses and by what mechanism the data will be shared.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept accessCriteria in dataset Core Metadata Schema (V3.3)
description |
Id | (2022‑11‑28)
Synonym | study_data_sharing_plan_description
Description | Additional information about data sharing
### Properties
No 3_0 | 1.17.35.5
Rationale | Description: Additional descriptive information providing more details about the data sharing, e.g. indication what data in particular will be shared or why the data will not be shared or why it is not yet decided.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: E.g., indication what data in particular will be shared or why the data will not be shared or why it is not yet decided
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept description in dataset Core Metadata Schema (V3.3)
datashield |
Id | (2022‑11‑28)
Synonym | study_data_sharing_plan_datashield
Description | Is the DataSHIELD/Opal infrastructure available?
### Properties
No 3_0 | 1.17.35.6
Rationale | Description: Indication, whether the DataSHIELD/Opal infrastructure is available.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Yes |  | code "373066001" (Yes (qualifier value)) from code system "SNOMED Clinical Terms"
No |  | code "373067005" (No (qualifier value)) from code system "SNOMED Clinical Terms"
Pending |  | code "C1611271" (Pending - status (Temporal Concept)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Study_Data_Sharing_Plan_Datashield_SNOMEDCT_UMLS (version 2023‑08‑29 15:50:18)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept datashield in dataset Core Metadata Schema (V3.3)
url |
Id | (2022‑11‑28)
Synonym | study_data_sharing_plan_url
Description | Web page with additional information about data sharing
### Properties
No 3_0 | 1.17.35.7
Rationale | Description: If existing, a link to the web page where additional information about data sharing can be found.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept url in dataset Core Metadata Schema (V3.3)
nonInterventional | link
Id | (2022‑11‑28)
Synonym | study_design_non_interventional
Description | Information about specific aspects of non-interventional studies/substudies
### Properties
No 3_0 | 1.17.36
Rationale | Description: Group of items providing information about specific aspects of interventional studies or substudies. Additional information: Group of items applicable only to non-interventional studies and substudies.
Source | NFDI4Health
Comment | Cardinality: 0..1, if study_primary_design =="Non-interventional"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept nonInterventional in dataset Core Metadata Schema (V3.3)
timePerspectives |
Id | (2022‑11‑28)
Synonym | study_time_perspectives
Description | Temporal design of the study
### Properties
No 3_0 | 1.17.36.1
Rationale | Description: Temporal design of the study, i.e. the relationship of observation period to time of participant enrollment.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Is it a retrospective, prospective or cross-sectional study?
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Retrospective | Look back using observations collected predominantly prior to subject selection and enrollment [NFDI4Health]. | code "155" (Retrospective) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Prospective | Look forward using periodic observations collected predominantly following subject enrollment [NFDI4Health]. | code "156" (Prospective) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Cross-sectional | Observations or measurements made at a single point in time, usually at subject enrollment [NFDI4Health]. | code "162" (Cross-sectional) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other | A time perspective that is not covered by any of the other values in this list [NFDI4Health]. | code "163" (Other (timePerspectives)) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set NFDI4Health_VS_MDS_Study_Time_Perspectives_Local (version 2023‑10‑25 14:08:45)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept timePerspectives in dataset Core Metadata Schema (V3.3)
targetFollowUpDuration |
Id | (2022‑11‑28)
Synonym | study_target_followup_duration
Description | Target follow-up duration
### Properties
No 3_0 | 1.17.36.2
Rationale | Description: If applicable, anticipated time period over which each participant is to be followed, provided in years.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: The value must be provided in years.
Value Domain | Quantity
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept targetFollowUpDuration in dataset Core Metadata Schema (V3.3)
biospecimenRetention |
Id | (2022‑11‑28)
Synonym | study_biospecimen_retention
Description | Which biosamples are retained in a biorepository?
### Properties
No 3_0 | 1.17.36.3
Rationale | Description: Indication whether samples of biomaterial from study participants are retained in a biorepository.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..*
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
None retained |  | code "C4289918" (Biospecimens Not Retained (Conceptual Entity)) from code system "Unified Medical Language System"
Samples with DNA |  | code "C4288286" (Retained Specimens Contain DNA (Conceptual Entity)) from code system "Unified Medical Language System"
Samples without DNA |  | code "C4288285" (Retained Specimens Do Not Contain DNA (Conceptual Entity)) from code system "Unified Medical Language System"
Value Set required NFDI4Health_VS_MDS_Study_Biospecimen_Retention_UMLS (version 2023‑08‑29 15:57:35)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept biospecimenRetention in dataset Core Metadata Schema (V3.3)
biospecimenDescription |
Id | (2022‑11‑28)
Synonym | study_biospecimen_description
Description | Specific types of retained biosamples
### Properties
No 3_0 | 1.17.36.4
Rationale | Description: Additional information about biosamples to be retained, i.e. which specific types of biospecimens will be retained (e.g. blood, serum, urine, etc.).
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1, if study_biospecimen_retention != "None retained"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Which specific types of biosamples will be retained (e.g. blood, serum, urine, etc.)?
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept biospecimenDescription in dataset Core Metadata Schema (V3.3)
interventional | link
Id | (2022‑11‑28)
Synonym | study_design_interventional
Description | Information about specific aspects of interventional studies/substudies
### Properties
No 3_0 | 1.17.37
Rationale | Description: Group of items providing information about specific aspects of interventional studies or substudies. Additional information: Group of items applicable only to interventional studies and substudies.
Source | NFDI4Health
Comment | Cardinality: 0..1, if study_primary_design =="Interventional"; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept interventional in dataset Core Metadata Schema (V3.3)
phase |
Id | (2022‑11‑28)
Synonym | study_phase
Description | Numerical phase of the study
### Properties
No 3_0 | 1.17.37.1
Rationale | Description: If applicable, numerical phase of the study.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Early-phase-1 | Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies) [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C54721" (Phase 0 Trial (Research Activity)) from code system "NCI Metathesaurus"
Phase-1 | Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C15600" (Phase I Trial (Research Activity)) from code system "NCI Metathesaurus"
Phase-1-phase-2 | Trials that are a combination of phases 1 and 2 [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C15693" (Phase I/II Trial (Research Activity)) from code system "NCI Metathesaurus"
Phase-2 | Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C15601" (Phase II Trial (Research Activity)) from code system "NCI Metathesaurus"
Phase-2a | A clinical research protocol generally referred to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C49686" (Phase IIa Trial (Research Activity)) from code system "NCI Metathesaurus"
Phase-2b | A clinical research protocol generally referred to as a well-controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C49688" (Phase II b Trial (Research Activity)) from code system "NCI Metathesaurus"
Phase-2-phase-3 | Trials that are a combination of phases 2 and 3 [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C15694" (Phase II/III Trial (Research Activity)) from code system "NCI Metathesaurus"
Phase-3 | Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C15602" (Phase III Trial (Research Activity)) from code system "NCI Metathesaurus"
Phase-3a | A classification typically assigned retrospectively to a Phase-3 trial upon determination by regulatory authorities of a need for a Phase-3b trial [DRKS (https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C49687" (Phase IIIa Trial (Research Activity)) from code system "NCI Metathesaurus"
Phase-3b | A type of Phase-3 trial executed near the time of approval to elicit additional findings. This type of trial may be required as a condition of regulatory authority approval [DRKS (https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C49689" (Phase IIIb Trial (Research Activity)) from code system "NCI Metathesaurus"
Phase-4 | Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use [DRKS (https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields)]. | code "C15603" (Phase IV Trial (Research Activity)) from code system "NCI Metathesaurus"
Other | A phase that is not covered by any of the other values in this list [NFDI4Health]. | code "C17649" (Other (Qualitative Concept)) from code system "NCI Metathesaurus"
Not applicable | Trials without phases (for example, studies of devices or behavioral interventions) [NFDI4Health]. | code "C48660" (Not Applicable (Qualitative Concept)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Study_Phase_NCI (version 2023‑08‑29 20:55:20)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept phase in dataset Core Metadata Schema (V3.3)
masking | link
Id | (2022‑11‑28)
Synonym | study_masking
Description | Information about masking of intervention(s) assignment
### Properties
No 3_0 | 1.17.37.2
Rationale | Description: Group of items providing information about the masking of intervention(s) assignment.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept masking in dataset Core Metadata Schema (V3.3)
general |
Id | (2022‑11‑28)
Synonym | study_masking_general
Description | Is masking of intervention(s) assignment implemented?
### Properties
No 3_0 | 1.17.37.2.1
Rationale | Description: Indication, whether a masking (or blinding) of intervention(s) assignment is implemented (i.e., whether someone is prevented from having knowledge of the interventions assigned to individual participants).
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Value Domain | Boolean
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept general in dataset Core Metadata Schema (V3.3)
roles |
Id | (2022‑11‑28)
Synonym | study_masking_roles
Description | Who is masked?
### Properties
No 3_0 | 1.17.37.2.2
Rationale | Description: If masking is implemented, the party(ies) who are masked.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..*, if study_masking == true; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Participant | Someone who takes part in an activity, e.g. a study [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C29867" (Participant) from code system "NCI Metathesaurus"
Care provider | A medical professional who provides, coordinates, or helps a patient access a range of health care services [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C16666" (Health Care Provider) from code system "NCI Metathesaurus"
Investigator | An individual who conducts scientific research. In a clinical setting this individual actually conducts and/or supervises the clinical investigation and study-related procedures [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C25936" (Investigator) from code system "NCI Metathesaurus"
Outcomes assessor | Outcomes accessor is an individual who evaluates the outcome(s) of interest, e.g. a statistician [NFDI4Health]. |
Value Set required NFDI4Health_VS_MDS_Study_Masking_Roles_NCI_Local (version 2023‑08‑29 21:15:49)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept roles in dataset Core Metadata Schema (V3.3)
description |
Id | (2022‑11‑28)
Synonym | study_masking_description
Description | Additional information about masking
### Properties
No 3_0 | 1.17.37.2.3
Rationale | Description: If needed, additional descriptive information about masking (e.g. information about other parties who may be masked).
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1, if study_masking == true; otherwise 0..0
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: If needed, additional information about masking, e.g. other parties who may be masked.
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept description in dataset Core Metadata Schema (V3.3)
allocation |
Id | (2022‑11‑28)
Synonym | study_allocation
Description | Type of allocation of participants to an arm
### Properties
No 3_0 | 1.17.37.3
Rationale | Description: Type of allocation/assignment of individual study participants to an arm.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Randomized | A type of allocation strategy in which participants are assigned to the arms/groups of a clinical trial by chance [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "159" (Randomized) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Nonrandomized | A type of allocation strategy in which participants are not assigned to the arms/groups of a clinical trial by chance [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "157" (Nonrandomized) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Not applicable (for single-arm trials) | Trials with just single arm [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "158" (Not applicable (for single-arm trials)) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set NFDI4Health_VS_MDS_Study_Allocation_Local (version 2023‑10‑25 14:50:59)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept allocation in dataset Core Metadata Schema (V3.3)
offLabelUse |
Id | (2022‑11‑28)
Synonym | study_off_label_use
Description | Off-label use of a drug product
### Properties
No 3_0 | 1.17.37.4
Rationale | Description: Unapproved (off-label) use of a drug product.
Source | DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): yes Display information? (Data visualization): yes
Operationalization | Short input help: Select "Yes" or "No" only for drug studies and "Not applicable” for all other studies.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Yes |  | code "373066001" (Yes (qualifier value)) from code system "SNOMED Clinical Terms"
No |  | code "373067005" (No (qualifier value)) from code system "SNOMED Clinical Terms"
Not applicable |  | code "385432009" (Not applicable (qualifier value)) from code system "SNOMED Clinical Terms"
Value Set required NFDI4Health_VS_MDS_Yes_No_Not_Applicable_SNOMEDCT (version 2023‑08‑28 21:57:28)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept offLabelUse in dataset Core Metadata Schema (V3.3)
provenance | link
Id | (2022‑11‑28)
Synonym | provenance
Description | Information about provenance aspects of the data entry
### Properties
No 3_0 | 1.18
Rationale | Description: Group of items providing information about provenance aspects of the data entry on the portal.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept provenance in dataset Module Design (V3.3) (v3.3)
dataSource |
Id | (2022‑11‑28)
Synonym | data_source
Description | Source of information about the [RESOURCE]
### Properties
No 3_0 | 1.18.1
Rationale | Description: Source of information about the resource and the way it was uploaded/collected.
Source | NFDI4Health
Comment | Cardinality: 1..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): yes
Value Domain | Code
Choice list |
Concept List
Concept | Description
Automatically uploaded: ClinicalTrials.gov |
Automatically uploaded: DRKS |
Automatically uploaded: ICTRP |
Automatically uploaded: MDM Portal |
Automatically uploaded: Other |
Manually collected |
Value Set required NFDI4Health_VS_MDS_Provenance_Data_Source_Local (version DYNAMIC)
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept dataSource in dataset Module Design (V3.3) (v3.3)
verificationDate |
Id | (2022‑11‑28)
Synonym | verification_date
Description | Verfication date
### Properties
No 3_0 | 1.18.2
Rationale | Description: Date on which the responsible party last verified the information about the resource, even if no additional or updated information is being submitted.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Value Domain | Date
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept verificationDate in dataset Module Design (V3.3) (v3.3)
verificationUser |
Id | (2022‑11‑28)
Synonym | verification_date_user
Description | User who last verified the [RESOURCE]
### Properties
No 3_0 | 1.18.3
Rationale | Description: User who last verified the information about the resource.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Value Domain | Code
Choice list |
Concept List
Concept | Description
Names from the list of users |
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept verificationUser in dataset Module Design (V3.3) (v3.3)
firstSubmittedDate |
Id | (2022‑11‑28)
Synonym | resource_first_submitted_date
Description | Date when the [RESOURCE] was first submitted for publication
### Properties
No 3_0 | 1.18.4
Rationale | Description: Date when the resource was first submitted for publication.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Value Domain | Date
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept firstSubmittedDate in dataset Module Design (V3.3) (v3.3)
firstSubmittedUser |
Id | (2022‑11‑28)
Synonym | resource_first_submitted_user
Description | User who first submitted the [RESOURCE] for publication
### Properties
No 3_0 | 1.18.5
Rationale | Description: User who first submitted the [RESOURCE] for publication.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Value Domain | Code
Choice list |
Concept List
Concept | Description
Names from the list of users |
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept firstSubmittedUser in dataset Module Design (V3.3) (v3.3)
firstPostedDate |
Id | (2022‑11‑28)
Synonym | resource_first_posted_date
Description | Date when the [RESOURCE] was first posted/published
### Properties
No 3_0 | 1.18.6
Rationale | Description: Date when the resource was first posted/published.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): yes
Value Domain | Date
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept firstPostedDate in dataset Module Design (V3.3) (v3.3)
firstPostedUser |
Id | (2022‑11‑28)
Synonym | resource_first_posted_user
Description | User who first posted/published the [RESOURCE]
### Properties
No 3_0 | 1.18.7
Rationale | Description: User who first posted/published the resource.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Value Domain | Code
Choice list |
Concept List
Concept | Description
Names from the list of users |
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept firstPostedUser in dataset Module Design (V3.3) (v3.3)
lastUpdateSubmittedDate |
Id | (2022‑11‑28)
Synonym | last_update_submitted_date
Description | Date when the last update of the resource was submitted for publication.
### Properties
No 3_0 | 1.18.8
Rationale | Description: Date when the last update of the resource was submitted for publication.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Value Domain | Date
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept lastUpdateSubmittedDate in dataset Module Design (V3.3) (v3.3)
lastUpdateSubmittedUser |
Id | (2022‑11‑28)
Synonym | last_update_submitted_user
Description | User who submitted the last update of the [RESOURCE]
### Properties
No 3_0 | 1.18.9
Rationale | Description: User who submitted the last update of the resource.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Value Domain | Code
Choice list |
Concept List
Concept | Description
Names from the list of users |
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept lastUpdateSubmittedUser in dataset Module Design (V3.3) (v3.3)
lastUpdatePostedDate |
Id | (2022‑11‑28)
Synonym | last_update_posted_date
Description | Date when the last update of the [RESOURCE] was posted/published
### Properties
No 3_0 | 1.18.10
Rationale | Description: Date when the last update of the resource was posted/published.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): yes
Value Domain | Date
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept lastUpdatePostedDate in dataset Module Design (V3.3) (v3.3)
lastUpdatePostedUser |
Id | (2022‑11‑28)
Synonym | last_update_posted_user
Description | User who posted/published the last update
### Properties
No 3_0 | 1.18.11
Rationale | Description: User who posted/published the last update.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Value Domain | Code
Choice list |
Concept List
Concept | Description
Names from the list of users |
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept lastUpdatePostedUser in dataset Module Design (V3.3) (v3.3)
resourceVersion |
Id | (2022‑11‑28)
Synonym | resource_version
Description | Version number of the resource within the portal/system
### Properties
No 3_0 | 1.18.12
Rationale | Description: Version number of the resource within the portal/system.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Comment | Display information? (Data capturing): no Display information? (Data visualization): no
Value Domain | String
Used by | 0 transactions, 0 templates, inherited once
| This concept is inherited by concept resourceVersion in dataset Module Design (V3.3) (v3.3)