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"
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")
0 … 0 Not permitted
0..0, 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")
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 1 … 1 Mandatory
Id
(2023‑11‑18)
Cardinality
1 … 1 Mandatory
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: Date on which the responsible party last verified the information about the [RESOURCE],
even if no additional or updated information is being submitted.
Transaction NFDI4Health Resource 2.16.840.1.113883.3.1937.777.64.4.4
Used by
