| Name |
Details [‑] |
|
Resource
|
|
|
| Id |
(2022‑11‑28) |
| Description |
Resource
|
|
|
| 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
|
|
|
identifier
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_identifier
|
| Description |
ID of the [Resource]
|
|
|
| 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 |
|
|
classification
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_classification
|
| Description |
Classification of the resource within the predefined categories
|
|
|
| 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
|
|
|
resourceType
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_type
|
| Description |
Type of the resource
|
|
|
| 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) |
|
|
|
resourceTypeGeneral
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_type_general
|
| Description |
A more general type of the resource
|
|
|
| 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) |
|
|
|
titles
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_titles
|
| Description |
Title(s)/name(s) of the [RESOURCE]
|
|
|
| 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
|
|
|
text
|
|
|
|
|
language
|
|
|
|
|
acronyms
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_acronyms
|
| Description |
Acronym(s) of the [RESOURCE]
|
|
|
| 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
|
|
|
text
|
|
|
|
|
language
|
|
|
|
|
descriptionEnglish
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_description_english
|
| Description |
English description of the [RESOURCE]
|
|
|
| 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
|
|
|
text
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
text
|
| Description |
English description of the [RESOURCE]
|
|
|
| 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 |
|
|
language
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
language
|
| Description |
Language of the description
|
|
|
| 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) |
|
|
|
|
descriptionNonEnglish
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_descriptions_non_english
|
| Description |
Additional description(s) of the [RESOURCE]
|
|
|
| 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
|
|
|
text
|
|
|
|
|
language
|
|
|
|
|
keywords
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_keywords
|
| Description |
Keyword(s) describing the [RESOURCE]
|
|
|
| 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
|
|
|
label
|
|
|
|
|
code
|
|
|
|
|
languages
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_languages
|
| Description |
Language(s) of the [RESOURCE]
|
|
|
| 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) |
|
|
|
webpage
|
|
|
|
|
nonStudyDetails
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_non_study_details
|
| Description |
Detailed information about the [RESOURCE]
|
|
|
| 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
|
|
|
version
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_version
|
| Description |
Version of the [RESOURCE]
|
|
|
| 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 |
|
|
format
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_format
|
| Description |
Format of the [RESOURCE]
|
|
|
| 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 |
|
|
useRights
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_use_rights
|
| Description |
Information about the rights to (re-)use the [RESOURCE]
|
|
|
| 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
|
|
|
label
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_use_rights_label
|
| Description |
License
|
|
|
| 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) |
|
|
|
confirmations
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_use_rights_confirmations
|
| Description |
Important nformation about licensing, if a Creative Commons liesense is selected.
|
|
|
| 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
|
|
|
authority
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_use_rights_confirmation_authority
|
| Description |
Do you confirm that the authors have authority to license the [RESOURCE]?
|
|
|
| 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 |
|
|
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?
|
|
|
| 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 |
|
|
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?
|
|
|
| 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 |
|
|
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?
|
|
|
| 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 |
|
|
description
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_use_rights_description
|
| Description |
Additional information about use rights
|
|
|
| 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 |
|
|
roles
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
roles
|
| Description |
Roles
|
|
|
| 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
|
|
|
nameType
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
role_name_type
|
| Description |
Type of the name
|
|
|
| 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) |
|
|
|
organisational
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
role_name_organisational_group
|
| Description |
Details about the organisation/institution/group/etc.
|
|
|
| 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.
|
|
|
type
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
role_name_organisational_group_type
|
| Description |
Type of the role
|
|
|
| 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) |
|
|
|
fundingId
|
|
|
|
|
name
|
|
|
|
|
personal
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
role_name_personal
|
| Description |
Details about the person
|
|
|
| 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
|
|
|
type
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
role_name_personal_type
|
| Description |
Type of the role
|
|
|
| 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) |
|
|
|
givenName
|
|
|
|
|
familyName
|
|
|
|
|
title
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
role_name_personal_title
|
| Description |
Title of the person. |
|
|
| 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) |
|
|
|
identifiers
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
role_name_identifiers
|
| Description |
Digital identifier(s) of the person
|
|
|
| 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
|
|
|
Identifier
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
identifier
|
| Description |
Identifier
|
|
|
| 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 |
|
|
scheme
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
scheme
|
| Description |
Which type of identifer is reported?
|
|
|
| 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 |
|
|
email
|
|
|
|
|
phone
|
|
|
|
|
affiliation
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
role_affiliations
|
| Description |
Further information about organisation(s) associated with the role
|
|
|
| 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
|
|
|
name
|
|
|
|
|
address
|
|
|
|
|
webpage
|
|
|
|
|
identifiers
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
role_affiliation_identifiers
|
| Description |
Digital identifier(s) of the organisation
|
|
|
| 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
|
|
|
Identifier
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
identifier
|
| Description |
Identifier
|
|
|
| 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 |
|
|
scheme
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
scheme
|
| Description |
Identifier scheme
|
|
|
| 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 |
|
|
idsAlternative
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
ids_alternative
|
| Description |
Alternative identifiers
|
|
|
| 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.
|
|
|
scheme
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
type
|
| Description |
Type of the register
|
|
|
| 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 |
|
|
Identifier
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
identifier
|
| Description |
Identifier
|
|
|
| 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 |
|
|
ids
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
ids
|
| Description |
Related publications, datasets, study documents, web pages, etc.
|
|
|
| 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.
|
|
|
identifier
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
identifier
|
| Description |
Identifier of the related resource
|
|
|
| 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 |
|
|
scheme
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
type
|
| Description |
Type of the identifier
|
|
|
| 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 |
|
|
date
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
date
|
| Description |
Date of ID assignment
|
|
|
| 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 |
|
|
relationType
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
relation_type
|
| Description |
Relationship between this [RESOURCE] (A) and the related resource (B)?
|
|
|
| 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 |
|
|
resourceTypeGeneral
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
resource_type_general
|
| Description |
Type of the related resource
|
|
|
| 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 |
|
|
idsNfdi4health
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
ids_nfdi4health
|
| Description |
Related (sub-)studies, study documents, etc. registered on this portal
|
|
|
| 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?
|
|
|
identifier
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
identifier
|
| Description |
Identifier of the related resource
|
|
|
| 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 |
|
|
relationType
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
relation_type
|
| Description |
Relationship between this [RESOURCE] (A) and the related resource (B)?
|
|
|
| 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) |
|
|
|
nutritionalData
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
nutritional_data
|
| Description |
Nutritional data collected?
|
|
|
| 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 |
|
|
chronicDiseases
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
chronic_diseases
|
| Description |
Chronic diseases included?
|
|
|
| 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 |
|
|
studyDesign
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_design
|
| Description |
Characteristics of the [RESOURCE]
|
|
|
| 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?
|
|
|
| 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) |
|
|
|
studyType
|
|
|
|
|
interventional
|
|
|
|
|
nonInterventional
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_type_non_interventional
|
| Description |
Specification of study type
|
|
|
| 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) |
|
|
|
studyConditions
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_conditions
|
| Description |
Primary health condition(s), disease(s) or focus of the study
|
|
|
| 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
|
|
|
label
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_conditions_label
|
| Description |
Name of the primary health condition, disease or focus of the study
|
|
|
| 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 |
|
|
classification
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_conditions_classification
|
| Description |
Terminology/classification
|
|
|
| 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 |
|
|
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
|
|
|
| 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 |
|
|
studyGroupsOfDiseases
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_groups_of_diseases
|
| Description |
Which groups of diseases or conditions were the data collected on?
|
|
|
| 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
|
|
|
generally
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_groups_of_diseases_generally
|
| Description |
Which groups of diseases or conditions were the data collected on?
|
|
|
| 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) |
|
|
|
conditions
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_diseases_conditions
|
| Description |
On which other diseases or conditions were the data collected?
|
|
|
| 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 |
|
|
mortalityData
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
mortality_data
|
| Description |
Were mortality data collected?
|
|
|
| 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) |
|
|
|
ethicsCommiteeApproval
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_ethics_committee_approval
|
| Description |
Status of the ethics committee approval
|
|
|
| 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) |
|
|
|
status
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_status
|
| Description |
Overall study status
|
|
|
| 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) |
|
|
|
statusWhenIntervention
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_status_when_intervention
|
| Description |
Do participants receive an intervention?
|
|
|
| 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) |
|
|
|
stageStopped
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_status_halted_stage
|
| Description |
At what stage was the study stopped?
|
|
|
| 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) |
|
|
|
reasonStopped
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_status_halted_reason
|
| Description |
Reason why the study was stopped
|
|
|
| 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 |
|
|
statusEnrollingByInvitation
|
|
|
|
|
recruitmentStatusRegister
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_recruitment_status_register
|
| Description |
Overall recruitment status of the study from the register of clinical trials
|
|
|
| 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) |
|
|
|
studyStartDate
|
|
|
|
|
studyEndDate
|
|
|
|
|
countries
|
|
|
|
|
region
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_region
|
| Description |
Regions and/or cities within a country where the study takes place
|
|
|
| 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 |
|
|
centers
|
|
|
|
|
centersNumber
|
|
|
|
|
subject
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_subject
|
| Description |
Primary study subject
|
|
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
| Unknown |
The study subject is unknown [NFDI4Health].
|
code "261665006" (Unknown (qualifier value)) from code system "SNOMED-CT"
|
|
| Value Set required NFDI4Health_VS_MDS_Study_Subject_SNOMEDCT (version 2023‑08‑28 23:18:11) |
|
|
|
sampling
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_sampling
|
| Description |
Sampling method
|
|
|
| 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.
|
|
|
method
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_sampling_method
|
| Description |
Applied sampling method
|
|
|
| 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) |
|
|
|
probabilityMethod
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_sampling_method_probability
|
| Description |
Specific type of probability sampling
|
|
|
| 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) |
|
|
|
nonProbabilityMethod
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_sampling_method_non_probability
|
| Description |
Specific type of non-probability sampling
|
|
|
| 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)].
|
code "174" (Purposive) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
|
|
| Value Set required NFDI4Health_VS_MDS_Study_Sampling_Method_Non_Probability_Local (version 2023‑10‑26 13:15:19) |
|
|
|
dataSource
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_data_source
|
| Description |
Data sources from which study data are generated or extracted.
|
|
|
| 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
|
|
|
general
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_data_sources_general
|
| Description |
Data sources for the study (e.g. biosamples, registries, questionnaires, etc.)
|
|
|
| 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) |
|
|
|
biosamples
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_data_sources_biosamples
|
| Description |
Biosamples collected in the study
|
|
|
| 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-CT"
|
| Buccal cells |
|
code "C172264" (Buccal Cell Sample (Cell)) from code system "NCI Metathesaurus"
|
| Cord blood |
|
code "12499000" (Cord blood (substance)) from code system "SNOMED-CT"
|
| DNA |
|
code "24851008" (Deoxyribonucleic acid (substance)) from code system "SNOMED-CT"
|
| Faeces |
|
code "39477002" (Feces (substance)) from code system "SNOMED-CT"
|
| Hair |
|
code "395508003" (Hair - material (substance)) from code system "SNOMED-CT"
|
| 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-CT"
|
| Plasma |
|
code "50863008" (Plasma (substance)) from code system "SNOMED-CT"
|
| RNA |
|
code "27888000" (Ribonucleic acid (substance)) from code system "SNOMED-CT"
|
| Saliva |
|
code "256897009" (Saliva (substance)) from code system "SNOMED-CT"
|
| Serum |
|
code "67922002" (Serum (substance)) from code system "SNOMED-CT"
|
| Tissue (frozen) |
|
code "16214131000119104" (Frozen tissue section specimen (specimen)) from code system "SNOMED-CT"
|
| Tissue (FFPE) |
|
code "441652008" (Formalin-fixed paraffin-embedded tissue specimen (specimen)) from code system "SNOMED-CT"
|
| Urine |
|
code "78014005" (Urine (substance)) from code system "SNOMED-CT"
|
| 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) |
|
|
|
imaging
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_data_sources_imaging
|
| Description |
Imaging data collected in the study
|
|
|
| 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) |
|
|
|
omics
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_data_sources_omics
|
| Description |
Omics technology used in the study
|
|
|
| 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) |
|
|
|
description
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_data_source_description
|
| Description |
Additional information about data sources
|
|
|
| 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 |
|
|
primaryPurpose
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_primary_purpose
|
| Description |
Primary purpose of the study
|
|
|
| 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) |
|
|
|
eligibilityCriteria
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_eligibility_criteria
|
| Description |
Eligibility criteria for study participants
|
|
|
| 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
|
|
|
ageMin
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_eligibility_age_min
|
| Description |
Eligibility criteria: Minimum age
|
|
|
| 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
|
|
|
number
|
|
|
|
|
timeUnit
|
|
|
|
|
ageMax
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_eligibility_age_max
|
| Description |
Eligibility criteria: Maximum age
|
|
|
| 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
|
|
|
number
|
|
|
|
|
timeUnit
|
|
|
|
|
genders
|
|
|
|
|
inclusionCriteria
|
|
|
|
|
exclusionCriteria
|
|
|
|
|
population
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_population
|
| Description |
Description of study population
|
|
|
| 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 |
|
|
targetSampleSize
|
|
|
|
|
obtainedSampleSize
|
|
|
|
|
ageMinExamined
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_age_min_examined
|
| Description |
Actual minimum age of participants
|
|
|
| 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
|
|
|
number
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
number
|
| Description |
Actual minimum age of participants
|
|
|
| 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 |
|
|
timeUnit
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
time_unit
|
| Description |
Unit of time
|
|
|
| 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) |
|
|
|
ageMaxExamined
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_age_max_examined
|
| Description |
Actual maximum age of participants
|
|
|
| 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
|
|
|
number
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
number
|
| Description |
Actual maximum age of participants
|
|
|
| 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 |
|
|
timeUnit
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
time_unit
|
| Description |
Unit of time
|
|
|
| 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) |
|
|
|
hypothesis
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_hypothesis
|
| Description |
Research questions and/or hypothesis underlying the study
|
|
|
| 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 |
|
|
armsGroups
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_arms_groups
|
| Description |
Arms or groups/cohorts of the study
|
|
|
| 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
|
|
|
label
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_arm_group_label
|
| Description |
Name of the arm/group
|
|
|
| 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 |
|
|
type
|
|
|
|
|
description
|
|
|
|
|
interventions
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_interventions
|
| Description |
Interventions/exposures of the study
|
|
|
| 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
|
|
|
name
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_intervention_name
|
| Description |
Name of the intervention/exposure
|
|
|
| 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 |
|
|
type
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_intervention_type
|
| Description |
Type of the intervention/exposure
|
|
|
| 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) |
|
|
|
description
|
|
|
|
|
armsGroupsLabel
|
|
|
|
|
studyOutcomes
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_outcomes
|
| Description |
Outcome measure(s)
|
|
|
| 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
|
|
|
type
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_outcome_type
|
| Description |
Type of the outcome measure
|
|
|
| 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) |
|
|
|
title
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_outcome_title
|
| Description |
Name of the outcome measure
|
|
|
| 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 |
|
|
description
|
|
|
|
|
timeFrame
|
|
|
|
|
comment
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_design_comment
|
| Description |
Any additional information about the study
|
|
|
| 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 |
|
|
assessments
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_assessments
|
| Description |
Further assessments/measurements included in the study
|
|
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
| 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) |
|
|
|
dataSharingPlan
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_data_sharing_plan
|
| Description |
Information about data sharing
|
|
|
| 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
|
|
|
generally
|
|
|
|
|
supportingInformation
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_data_sharing_plan_supporting_information
|
| Description |
Supporting documents available in addition to the data
|
|
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
| 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-CT"
|
|
| Value Set required NFDI4Health_VS_MDS_Study_Data_Sharing_Plan_Supporting_Information_UMLS_Local (version 2023‑08‑29 15:46:25) |
|
|
|
timeFrame
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_data_sharing_plan_time_frame
|
| Description |
When and for how long will the data be available?
|
|
|
| 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 |
|
|
accessCriteria
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_data_sharing_plan_access_criteria
|
| Description |
Criteria for the data access
|
|
|
| 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 |
|
|
description
|
|
|
|
|
datashield
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_data_sharing_plan_datashield
|
| Description |
Is the DataSHIELD/Opal infrastructure available?
|
|
|
| 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-CT"
|
| No |
|
code "373067005" (No (qualifier value)) from code system "SNOMED-CT"
|
| 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) |
|
|
|
url
|
|
|
|
|
nonInterventional
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_design_non_interventional
|
| Description |
Information about specific aspects of non-interventional studies/substudies
|
|
|
| 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
|
|
|
timePerspectives
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_time_perspectives
|
| Description |
Temporal design of the study
|
|
|
| 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) |
|
|
|
targetFollowUpDuration
|
|
|
|
|
biospecimenRetention
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_biospecimen_retention
|
| Description |
Which biosamples are retained in a biorepository?
|
|
|
| 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) |
|
|
|
biospecimenDescription
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_biospecimen_description
|
| Description |
Specific types of retained biosamples
|
|
|
| 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 |
|
|
interventional
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_design_interventional
|
| Description |
Information about specific aspects of interventional studies/substudies
|
|
|
| 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
|
|
|
phase
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_phase
|
| Description |
Numerical phase of the study
|
|
|
| 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) |
|
|
|
masking
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_masking
|
| Description |
Information about masking of intervention(s) assignment
|
|
|
| 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
|
|
|
general
|
|
|
|
|
roles
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_masking_roles
|
| Description |
Who is masked?
|
|
|
| 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) |
|
|
|
description
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
study_masking_description
|
| Description |
Additional information about masking
|
|
|
| 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 |
|
|
allocation
|
|
|
|
|
offLabelUse
|
|
|
|
|
provenance
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
provenance
|
| Description |
Information about provenance aspects of the data entry
|
|
|
| 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
|
|
|
dataSource
|
|
|
| Id |
(2022‑11‑28) |
| Synonym |
data_source
|
| Description |
Source of information about the [RESOURCE]
|
|
|
| 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) |
|
|
|
verificationDate
|
|
|
|
|
verificationUser
|
|
|
|
|
firstSubmittedDate
|
|
|
|
|
firstSubmittedUser
|
|
|
|
|
firstPostedDate
|
|
|
|
|
firstPostedUser
|
|
|
|
|
lastUpdateSubmittedDate
|
|
|
|
|
lastUpdateSubmittedUser
|
|
|
|
|
lastUpdatePostedDate
|
|
|
|
|
lastUpdatePostedUser
|
|
|
|
|
resourceVersion
|
|
|
|
|