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rejected Transaction NFDI4Health Resource 2.16.840.1.113883.3.1937.777.64.4.18

Data Set Core Metadata Schema 2.16.840.1.113883.3.1937.777.64.1.2

Name Id
rejected NFDI4Health Resource 2.16.840.1.113883.3.1937.777.64.4.18
Effective date Expiration date
2025‑02‑27
Description
Name Details [‑]
folder final Resource 1 … 1 Mandatory
Id (2024‑12‑06 11:25:57)
Cardinality 1 … 1 Mandatory
Description

Resource

Properties

Resource

Resource

Relationship
Rationale

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 studies or substudies.

Source

NFDI4Health

Comment

Cardinality: 1..1

target Used by 4 transactions, 0 templates, inherited 0 times
 
final identifier 1 … 1 Mandatory
Id (2024‑12‑06 11:25:57)
Cardinality 1 … 1 Mandatory
notice There is an open issue with this item:
  • nfdhtfcov19-issue-38: Identifiers of a resource - Resource.identifier and Resource.idsAlternative (Open)
Description

Identifier

Properties

Resource.identifier

Resource.identifier

Relationship
Rationale

Unique identifier of the resource used for identification within the NFDI4Health.

Source

NFDI4Health

DataCite [ https://doi.org/10.14454/3w3z-sa82]

Comment

Additional information: The identifier is assigned automatically.

Comment

Cardinality: 1..1

Value Domain String
target Used by 4 transactions, 0 templates, inherited once
 
folder final classification 1 … 1 Mandatory
Id (2024‑12‑06 11:25:57)
Cardinality 1 … 1 Mandatory
Description

Resource classification

Properties

Resource.classification

Resource.classification

Relationship
Rationale

Group of items providing information about the classification of the resource within the predefined categories.

Source NFDI4Health
Comment

Cardinality: 1..1

target Used by 4 transactions, 0 templates, inherited once
 
final type 1 … 1 Mandatory
Id (2024‑12‑06 11:25:57)
Cardinality 1 … 1 Mandatory
notice There is an open issue with this item:
Description

Type of the resource

Properties

Resource.classification.type

Resource.classification.type

Relationship
Rationale

A term describing the resource.

Source

DataCite [ https://doi.org/10.14454/3w3z-sa82]

Comment

Additional information: The selected resource type determines which information will be asked next.

Comment

Cardinality: 1..1

Operationalization

You can register a study, a study protocol, a questionnaire, etc.

Please only add follow-up questionnaires if baseline questionnaires have already been registered.

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 "C63536" (Study) from code system "FDA RouteOfAdministration"
Substudy

A part of a study [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)].

code "C198230" (Substudy) from code system "FDA RouteOfAdministration"
Dataset

Data encoded in a defined structure [DataCite (https://doi.org/10.14454/3w3z-sa82)].

code "C47824" (Data Set) from code system "FDA RouteOfAdministration"
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 "C93381" (Study Protocol Document) from code system "FDA RouteOfAdministration"
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 "C16468" (Consent Form) from code system "FDA RouteOfAdministration"
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 "C15518" (Clinical Trials Information for Patients) from code system "FDA RouteOfAdministration"
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 "C115779" (Standard Operating Procedure List) from code system "FDA RouteOfAdministration"
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 "C115761" (Statistical Analysis Plan) from code system "FDA RouteOfAdministration"
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 "C115756" (Data Management Plan) from code system "FDA RouteOfAdministration"
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 "C40988" (Case Report Form) from code system "FDA RouteOfAdministration"
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 "C17048" (Questionnaire) from code system "FDA RouteOfAdministration"
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 "C17649" (Other) from code system "FDA RouteOfAdministration"
Registry

A registry is a collection of information about individuals, usually focused around a specific diagnosis or condition [NIH (https://www.nih.gov/)].

code "C61393" (Registry) from code system "FDA RouteOfAdministration"
Secondary data source

Secondary data sources are comprised of data originally collected for purposes other than the registry under consideration (e.g., standard medical care, insurance claims processing) [NIH (https://www.nih.gov/)].

code "178" (Secondary data source) from code system "NFDI4Health_CS_MDS_Remaining_Concepts3.3"
Biobank

A biobank is a repository that stores and manages biological samples known as biospecimens for use in research [NIH (https://www.nih.gov/)].

code "C48800" (Biorepository) from code system "FDA RouteOfAdministration"

Value Set required NFDI4Health_VS_MDS_Resource_Type_NCI_Local (version 2023‑12‑13 14:11:50)
target Used by 4 transactions, 0 templates, inherited once
 
final typeGeneral Conditional
Id (2024‑12‑06 11:25:57)
Cardinality Conditional

Card/Conf Condition
1 … 1 Mandatory Resource.classification.type != ('Study' OR 'Substudy' OR 'Dataset' OR 'Registry' OR 'Secondary data source')
0 … 0 Not permitted Resource.classification.type == ('Study' OR 'Substudy' OR 'Dataset' OR 'Registry' OR 'Secondary data source')

Description

In what form is the [RESOURCE] available?

Properties

Resource.classification.typeGeneral

Resource.classification.typeGeneral

Relationship
Rationale

Specific information about the form in which the [RESOURCE] is available.

Source

DataCite [ https://doi.org/10.14454/3w3z-sa82]

Comment

Additional information: If the [RESOURCE] consists primarily of words for reading and is not covered by another textual resource type in this list, 'Text' should be used instead of 'Other'.

Comment

Cardinality: 1..1, if Resource.classification.type != ('Study' OR 'Substudy' OR 'Dataset' OR 'Registry' OR 'Secondary data source'); otherwise 0..0

Comment

Cardinality: 1..1, if Resource.classification.type != ('C63536' OR 'C198230' OR 'C47824' OR 'C61393' OR '178'); otherwise 0..0

Operationalization

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 "D001877" (Book Chapter) from code system "MeSH"
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 "D003226" (Conference Proceedings as Topic) from code system "MeSH"
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 "D019478" (Academic Dissertations) from code system "MeSH"
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 "D016428" (Journal Article) from code system "MeSH"
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 "260787004" (Physical object) from code system "SNOMED Clinical Terms"
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 "D000076942" (Pre-Print) from code system "MeSH"
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_MSH_Local (version 2024‑01‑02 12:04:20)
target Used by 4 transactions, 0 templates, inherited once
 
folder final titles 1 … 1 Mandatory
Id (2024‑12‑06 11:25:57)
Cardinality 1 … 1 Mandatory
Description

Titles/names

Properties

Resource.titles

Resource.titles

Relationship
Rationale

Group of items providing information about title(s)/name(s) of the [RESOURCE].

Source NFDI4Health
Comment

Cardinality: 1..*

target Used by 4 transactions, 0 templates, inherited once
 
final text 1 … 1 Mandatory
Id (2024‑12‑06 11:25:57)
Cardinality 1 … 1 Mandatory
Description

Title/name

Properties

Resource.titles.text

Resource.titles.text

Relationship
Rationale

Scientific unabbreviated title or name of the [RESOURCE].

Source

NFDI4Health

DataCite [ https://doi.org/10.14454/3w3z-sa82]

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Additional information: If no official title/name has been defined yet, a title/name that is suitable for public display should be used.

Comment

Cardinality: 1..1

Operationalization

Please provide at least one title/name of the [RESOURCE]. If the original title is not in English, please also provide an English translation of the original title.

Value Domain String
target Used by 4 transactions, 0 templates, inherited once
 
final language 1 … 1 Mandatory
Id (2024‑12‑06 11:25:57)
Cardinality 1 … 1 Mandatory
notice There is an open issue with this item:
Description

Language of the title/name

Properties

Resource.titles.language

Resource.titles.language

Relationship
Rationale

Language in which the title/name is provided.

Source

NFDI4Health

DataCite [ https://doi.org/10.14454/3w3z-sa82]

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Cardinality: 1..1

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)
target Used by 4 transactions, 0 templates, inherited once
 
folder final acronyms 0 … 1
Id (2024‑12‑06 11:25:57)
Cardinality 0 … 1
Description

Acronyms

Properties

Resource.acronyms

Resource.acronyms

Relationship
Rationale

Group of items providing information about acronym(s) or alternative short title(s)/name(s) of the [RESOURCE].

Source NFDI4Health
Comment

Cardinality: 0..*

target Used by 4 transactions, 0 templates, inherited once
 
final text 1 … 1 Mandatory
Id (2024‑12‑06 11:25:57)
Cardinality 1 … 1 Mandatory
Description

Acronym

Properties

Resource.acronyms.text

Resource.acronyms.text

Relationship
Rationale

If existing, acronym(s) of the [RESOURCE].

Source

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Additional information: The field refers primarily to resources which have an acronym.

Comment

Cardinality: 1..1

Operationalization

If no acronym exists, you can provide a short title, preferably up to 5 words, e.g. 'NAKO-COVID Questionnaire'.

Value Domain String
target Used by 4 transactions, 0 templates, inherited once
 
final language 1 … 1 Mandatory
Id (2024‑12‑06 11:25:57)
Cardinality 1 … 1 Mandatory
Description

Language of the acronym

Properties

Resource.acronyms.language

Resource.acronyms.language

Relationship
Rationale

Language in which the acronym is provided.

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

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)
target Used by 4 transactions, 0 templates, inherited once