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
4 transactions, 0 templates, inherited 0 times
This concept is used in transaction NFDI4Health Resource (3.3.1) (1 … 1 Mandatory) in scenario Core MDS (2) (v3.3.1)
This concept is used in transaction NFDI4Health Resource (1 … 1 Mandatory) in scenario Core MDS (2) (v3.3.1)
This concept is used in transaction NFDI4Health Resource (1 … 1 Mandatory) in scenario Core MDS (v3.3.1)
Additional information: The selected resource type determines which information will be asked next.
Comment
Cardinality: 1..1
Operationalization
You can register a study, a study protocol, a questionnaire, etc.
Please only add follow-up questionnaires if baseline questionnaires have already been
registered.
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
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
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.