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 studies or substudies.
Source
NFDI4Health
Comment
Cardinality: 1..1
Used by
one transaction, 0 templates, inherited 0 times
This concept is used in transaction NFDI4Health Resource (v3.3) (1 … 1 Mandatory) in scenario Core MDS (v3.3)
Additional information: The selected resource type determines which information will be asked next.
Comment
Cardinality: 1..1
Operationalization
Short input help: You can register a study, a study protocol, a questionnaire, etc.
Please only add follow up questionnaires if baseline questionnaires have already been
registered.
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"
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"
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"
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"
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
Short input help: You can select 'Text' for most of the study documents, e.g. for questionnaires, informed
consent forms, case report forms, etc.
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"
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"
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"
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"
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"
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"
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"
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"
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
Short input help: Please provide at least one title/name of the [RESOURCE]. If the original title is
not in English, please also provide an English translation of the original title.
Short input help: Please provide a description in the original language of the [RESOURCE]. If the original
language is not English, please also provide a full English translation of the description.
Additional information: The use of terms from established classifications/vocabularies (e.g. SNOMED CT, MeSH,
UMLS) is preferred. However, also self-assigned keywords are allowed.
Comment
Cardinality: 1..1
Operationalization
Short input help: Preferably, use terms from SNOMED CT or MESH.
Short input help: Select one value from the list.
If 'Other' is selected, please provide an explanation of the (re-)use terms and conditions
in the field 'Additional information about use rights'.
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)
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 "74964007" (Other) from code system "SNOMED Clinical Terms"
Not applicable
The license is not applicable for the resource [NFDI4Health].
code "385432009" (Not Applicable (qualifier value)) from code system "SNOMED Clinical Terms"
Unknown
It is unknown whether there is a license defining the use rights of the resource [NFDI4Health].
code "261665006" (Unknown (qualifier value)) from code system "SNOMED Clinical Terms"
Not assigned
No license has been assigned [NFDI4Health].
code "180" (Not assigned) from code system "NFDI4Health_CS_MDS_Remaining_Concepts3.3"
Description: Group of items applicable only if a Creative Commons license is selected.
Source
NFDI4Health
Comment
Additional information: In order to successfully publish the [RESOURCE] under the respective license, all
four questions ought to be confirmed.
Comment
Cardinality: 1..1, if Resource.nonStudyDetails.useRights.label != ('CC0 1.0 (Creative Commons
Zero v1.0 Universal)' OR 'All rights reserved' OR 'Other' OR 'Not applicable' OR 'Unknown');
otherwise 0..0
Comment
Cardinality: 1..1, if Resource.nonStudyDetails.useRights.label != ('CC0-1.0' OR '013' OR '74964007'
OR '385432009' OR '261665006'); otherwise 0..0
Used by
one transaction, 0 templates, inherited 0 times
This concept is used in transaction NFDI4Health Resource (v3.3) (0 … 1 Conditional) in scenario Core MDS (v3.3)
authority
Id
(2023‑11‑18)
Description
Do you confirm that the authors of the [RESOURCE] have authority to license it?
Additional information: If 'Other' is selected in the field 'License', the preferred license or terms and
conditions for (re-)use should be specified here.
Description: Group of items providing information about person(s), group(s) of persons or institution(s)/organisation(s)
contributing to the [RESOURCE].
Source
NFDI4Health
Comment
Additional information: For each [RESOURCE], there may be multiple contributors, but at least one person,
group of persons or institution/organisation must be specified.
Comment
Cardinality: 1..*
Used by
one transaction, 0 templates, inherited 0 times
This concept is used in transaction NFDI4Health Resource (v3.3) (1 … * Mandatory) in scenario Core MDS (v3.3)
Description: Contributor type an organisation, institution or group fulfills. For example, this
can be a sponsor of the study or a group of authors of the document.
(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"
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"
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) from code system "FDA RouteOfAdministration"
code "C19924" (Principal Investigator) from code system "FDA RouteOfAdministration"
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) from code system "FDA RouteOfAdministration"
code "C115486" (Content Item Creator) from code system "FDA RouteOfAdministration"
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"
code "C142695" (Sponsor-Investigator) from code system "FDA RouteOfAdministration"
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) from code system "FDA RouteOfAdministration"
code "C43368" (Editor) from code system "FDA RouteOfAdministration"
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) from code system "FDA RouteOfAdministration"
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"
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 "C17089" (Research Personnel) from code system "FDA RouteOfAdministration"
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) from code system "FDA RouteOfAdministration"
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) from code system "FDA RouteOfAdministration"
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"
Short input help: If you have already entered the name of the organistion in the field 'Name of the
organisation/institution/group', please repeat it here.
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"
Description: Group of items providing information about identifiers (IDs) assigned to the given
[RESOURCE] by another registering systems, e.g. a registry of clinical trials or a
data repository.
Description: Identifier (ID) assigned to the given [RESOURCE] by another registering system, e.g.
by a registry of clinical trials or a data repository.
Short input help: If the [RESOURCE] is registered in other systems (e.g. a registry of clinical trials
or a data repository), you can provide here corresponding identifier(s) such as DRKS00021273,
NCT04327505, etc.
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.
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.
Additional information: 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.
Comment
Cardinality: 1..1
Operationalization
Short input help: If existing, you can specify here identifier(s) of any related resources, e.g. DOIs
of publications, datasets, study documents, links to web pages, etc.
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 "C71462" (Digital Object Identifier) from code system "FDA RouteOfAdministration"
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 "C42743" (Uniform Resource Locator) from code system "FDA RouteOfAdministration"
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 "C54106" (Handle) from code system "FDA RouteOfAdministration"
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 "C47841" (Life Sciences Identifier) from code system "FDA RouteOfAdministration"
code "C127797" (PubMed Unique Identifier) from code system "FDA RouteOfAdministration"
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 "C71581" (Uniform Resource Name) from code system "FDA RouteOfAdministration"
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 "C17649" (Other) from code system "FDA RouteOfAdministration"
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"
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"
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"
code "079" (A obsoletes B) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
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"
Description: Indication whether the [RESOURCE] collects nutritional data.
Source
NFDI4Health UC 5.1 requirements
Comment
Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Resource.provenance.dataSource
== 'Manually collected'; otherwise 0..0
Comment
Cardinality: 1..1, if Resource.classification.type == ('C63536' OR 'C198230') AND Resource.provenance.dataSource
== '06'; otherwise 0..0
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
(2023‑11‑18)
Concept inherits from
(2022‑11‑28)
Synonym
study_primary_design
Description
Is it an interventional or non-interventional study?
Properties
No 3_0
1.17.1
Rationale
Description: Non-interventional study design refers to a study that does not aim to alter study
outcomes of interest. Interventional study design refers to a study that aims to alter
study outcomes of interest.
(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"
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"
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"
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"
Primary health condition(s), disease(s) or focus of the study
Properties
No 3_0
1.17.3
Rationale
Description: Group of items providing information about primary health condition(s) or disease(s)
considered in the study, or the focus of the study (e.g. medication, food, therapy,
device, etc.).
Source
NFDI4Health
Comment
Cardinality: 0..*
Comment
Display information? (Data capturing): yes
Display information? (Data visualization): yes
label
Id
(2023‑11‑18)
Concept inherits from
(2022‑11‑28)
Synonym
study_conditions_label
Description
Name of the primary health condition, disease or focus of the study
Properties
No 3_0
1.17.3.1
Rationale
Description: Name of primary health condition or disease considered in the study, or the focus
of the study (e.g. medication, food, therapy, device, etc.).
Additional information: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD,
etc.) is preferred. However, also self-assigned terms are allowed.
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"
Which groups of diseases or conditions were the data collected on?
Properties
No 3_0
1.17.4
Rationale
Description: Group of items providing information about groups of diseases or conditions on which
the data were collected in the study.
Source
NFDI4Health
Comment
Cardinality: 1..1
Comment
Display information? (Data capturing): yes
Display information? (Data visualization): yes
generally
Id
(2023‑11‑18)
Concept inherits from
(2022‑11‑28)
Synonym
study_groups_of_diseases_generally
Description
Which groups of diseases or conditions were the data collected on?
Properties
No 3_0
1.17.4.1
Rationale
Description: Groups of diseases or conditions on which the data were collected in the study.
Additional information: The values originate from the WHO's International Statistical Classification of Diseases
and Related Health Problems, 11th Revision (ICD-11).
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.
On which other diseases or conditions were the data collected?
Properties
No 3_0
1.17.4.2
Rationale
Description: Other diseases or conditions on which the data were collected in the study.
Additional information: The values originate from the WHO's International Statistical Classification of Diseases
and Related Health Problems, 11th Revision (ICD-11).
Cardinality: 0..1, if study_type_non_interventional == ("Longitudinal" OR "Cohort" OR "Case-cohort"
OR "Birth cohort" OR "Trend" OR "Panel"); otherwise 0..0
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".
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"
Description: Specification whether study participants receive intervention or have completed it
but are still being followed according to the primary objective of the study.
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
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
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"
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.
Description: In case of studies with patients or other participants, it is the date when the last
participant is examined or receives an intervention, or the date of the last participant’s
last visit.
Additional information: Preferred date format: DD.MM.YYYY.
code "125676002" (Person (person)) from code system "SNOMED Clinical Terms"
Animal
A non-human living organism that has membranous cell walls, requires oxygen and organic
foods, and is capable of voluntary movement, as distinguished from a plant or mineral
[NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt),
NFDI4Health].
code "387961004" (Kingdom Animalia (organism)) from code system "SNOMED Clinical Terms"
Other
A study subject that is not covered by any of the other values in this list [NFDI4Health].
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
Unknown
The study subject is unknown [NFDI4Health].
code "261665006" (Unknown (qualifier value)) from code system "SNOMED Clinical Terms"
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"
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"
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)].
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.
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.
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.
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"
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"
Description: Obtained number of observational units for the whole study (e.g. obtained number of
study participants at all study sites). The value is only available after the end
of recruitment.
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
(2023‑11‑18)
Concept inherits from
(2022‑11‑28)
Synonym
study_arm_group_label
Description
Name of the arm/group
Properties
No 3_0
1.17.30.1
Rationale
Description: Short name used to identify the arm/group.
Additional information: For interventional studies: "Arm" means a pre-specified group or subgroup of participant(s)
in a clinical trial assigned to receive specific intervention(s) (or no intervention)
according to a protocol. For non-interventional studies: "Group" means a predefined
group (cohort) of participants to be studied.
Description: Additional descriptive information about the given arm/group.
Additional information: For interventional studies: If needed, additional descriptive information (including
which interventions are administered in each arm) to differentiate each arm from other
arms in the clinical trial. For non-interventional studies: Explanation of the nature
of the study group (for example, those with a condition and those
without a condition; those with an exposure and those without an exposure).
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.
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"
(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"
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.
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.
Description: Description of the time point(s) at which the measurement for the outcome is assessed,
e.g. the specific duration of time over which each participant is assessed.
Information about the consumption of food (e.g. type, quantity and frequency of food
intake) and associated behaviours. Also see Dom. 7 'Medication and supplements', under
'Medication and supplement intake' for information about the consumption of vitamins
and supplements [Maelstrom (doi: 10.1371/journal.pone.0200926)].
code "C1511900" (Diet and nutrition (Research Activity)) from code system "Unified Medical Language System"
Physical activity
Information about the type, frequency and intensity of physical activity such as exercises
and sports (e.g. jogging, playing hockey), daily activities (e.g. household chores,
walking the dog) or sedentarity (e.g. lounging on the couch) [Maelstrom (doi: 10.1371/journal.pone.0200926)].
code "398636004" (Physical activity assessment (procedure)) from code system "SNOMED Clinical Terms"
Tobacco use
Information about the consumption of tobacco in any form (e.g. quantity and frequency
of smoking, chewing or sniffing) and associated behaviors [Maelstrom (doi: 10.1371/journal.pone.0200926)].
code "711013002" (Assessment of tobacco use (procedure)) from code system "SNOMED Clinical Terms"
Alcohol consumption
Information about the consumption of alcoholic beverages (e.g. frequency, quantity
and type of alcohol consumed) and associated behaviors [Maelstrom (doi: 10.1371/journal.pone.0200926)].
code "713127001" (Assessment of alcohol use (procedure)) from code system "SNOMED Clinical Terms"
code "14456009" (Measuring height of patient (procedure)) from code system "SNOMED Clinical Terms"
Waist circumference
A circumferential measurement of the waist, which may be classified as the area immediately
below the lowest rib, at the narrowest part of the torso, midpoint between the lowest
rib and the iliac crest, or immediately above the iliac crest [NCIT (https://github.com/NCI-Thesaurus/thesaurus-obo-edition)].
code "445396007" (Measurement of circumference of waist (procedure)) from code system "SNOMED Clinical Terms"
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
Id
(2023‑11‑18)
Concept inherits from
(2022‑11‑28)
Synonym
study_data_sharing_plan_generally
Description
Is it planned to share the data?
Properties
No 3_0
1.17.35.1
Rationale
Description: Indication whether there is a plan to make data collected in the study available.
In case of studies with patients or other individuals, this refers to individual participant
data (IPD).
A document describing the data, including metadata, and their meaning, usage, and
relationship to other data [NFDI4Health].
Study protocol
The formal plan of an experiment or research activity, including the objective, rationale,
design, materials and methods for the conduct of the study; intervention description,
and method of data analysis [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO
Library edition of NCIt)].
code "C2348563" (Study Protocol (Intellectual Product)) from code system "SNOMED Clinical Terms"
Protocol amendment
A written description of a change(s) to, or formal clarification of, a protocol [NCI
(GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)].
code "C4321383" (Protocol Amendment (Intellectual Product)) from code system "SNOMED Clinical Terms"
Statistical analysis plan
A document that contains a more technical and detailed elaboration of the principal
features of the analysis described in the protocol, and includes detailed procedures
for executing the statistical analysis of the primary and secondary variables and
other data [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition
of NCIt)].
code "C3889277" (Statistical Analysis Plan (Intellectual Product)) from code system "SNOMED Clinical Terms"
Analytic code
A document that contains a code that extracts, manages, and analyses data [NFDI4Health].
Informed consent form
A template of a document explaining all the relevant information to assist an individual
in understanding the expectations and risks in making a decision about a procedure.
This document is presented to and signed by the individual or guardian [NCI (GitHub
- NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)].
code "C0009797" (Consent Forms (Intellectual Product)) from code system "SNOMED Clinical Terms"
Clinical study report
A written description of a study of any therapeutic, prophylactic, or diagnostic agent
conducted in human subjects, in which the clinical and statistical description, presentations,
and analysis are fully integrated into a single report [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition:
OBO Library edition of NCIt)].
code "C4553084" (Clinical study report (Intellectual Product)) from code system "SNOMED Clinical Terms"
Manual of operations (SOP)
Detailed, written instructions to achieve uniformity of the performance of a specific
function [EMA (European Medicines Agency - ICH: E 6 (R2): Guideline for good clinical
practice - Step 5 (europa.eu))].
code "C3889288" (Standard Operating Procedure List (Intellectual Product)) from code system "SNOMED Clinical Terms"
Case report form (template)
A printed, optical, or electronic document designed to record all of the clinical
study-required information stipulated in the protocol to be reported to the sponsor
on each clinical trial subject [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition:
OBO Library edition of NCIt)].
code "C1516308" (Case Report Form (Intellectual Product) ) from code system "SNOMED Clinical Terms"
code "C0034394" (Questionnaires (Intellectual Product)) from code system "SNOMED Clinical Terms"
Code book
Pre-defined categorization scheme used for content coding, a data collection technique
to transform qualitative data (textual, video, audio or still-image) originally produced
for other purposes into quantitative data [DDI (https://ddialliance.org/Specification/DDI-CV/TypeOfInstrument_1.1.html)].
Other
A study document that is not covered by any of the other values in this list [NFDI4Health].
code "C0205394" (Other (Qualitative Concept)) from code system "SNOMED Clinical Terms"
Description: Additional descriptive information providing more details about the data sharing,
e.g. indication what data in particular will be shared or why the data will not be
shared or why it is not yet decided.
Description: Additional information about biosamples to be retained, i.e. which specific types
of biospecimens will be retained (e.g. blood, serum, urine, etc.).
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"
Information about masking of intervention(s) assignment
Properties
No 3_0
1.17.37.2
Rationale
Description: Group of items providing information about the masking of intervention(s) assignment.
Source
NFDI4Health
Comment
Cardinality: 0..1
Comment
Display information? (Data capturing): yes
Display information? (Data visualization): yes
general
Id
(2023‑11‑18)
Concept inherits from
(2022‑11‑28)
Synonym
study_masking_general
Description
Is masking of intervention(s) assignment implemented?
Properties
No 3_0
1.17.37.2.1
Rationale
Description: Indication, whether a masking (or blinding) of intervention(s) assignment is implemented
(i.e., whether someone is prevented from having knowledge of the interventions assigned
to individual participants).
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].
Description: Date on which the responsible party last verified the information about the [RESOURCE],
even if no additional or updated information is being submitted.
Data Set Core Metadata Schema (V3.3) 2.16.840.1.113883.3.1937.777.64.1.2
Used by
descriptionNonEnglish
