NCPI FHIR Implementation Guide
0.2.0 - ci-build

NCPI FHIR Implementation Guide - Local Development build (v0.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Logical Model: CDM Research Study

Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/common-data-model-research-study Version: 0.2.0
Active as of 2024-03-04 Computable Name: CdmResearchStudy

The CDM Research Study is a logical model intended to represent the real world concept of a scientific research study to be used when describing NCPI Profiles and how their attributes are mapped to actual study properties.

With regard to this Implementation Guide, a research study is a collection of data gathered through a systematic investigation aimed at acquiring insights into healthcare-related topics. A research study can encompass a standalone unit or consists of sub-studies often hosted in public databases, such as dbGaP. The study, or studies, may or may not be integrated into a broader consortia of research studies and is composed of the following elements described below.

Usage:

  • This Logical Model Profile is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from Base

NameFlagsCard.TypeDescription & Constraintsdoco
.. common-data-model-research-study 0..*BaseCDM Research Study
Instances of this logical model are not marked to be the target of a Reference
... consortium Σ0..1stringConsortium
... accession Σ1..1stringStudy Accession Number
... name Σ1..1stringStudy Name
... description 1..1stringThe study's description
... disease_focus 0..*CodingDisease or focus of the study
... attribution 0..*stringAttribution
... weblinks 0..*stringWeb Links
... study_design 0..*CodingStudy Design
... study_type 0..*CodingStudy Type
... citation 0..*stringCitation(s) associated with this study
... study_documents 0..*stringStudy Documents

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. common-data-model-research-study 0..*BaseCDM Research Study
Instances of this logical model are not marked to be the target of a Reference
... consortium Σ0..1stringConsortium
... accession Σ1..1stringStudy Accession Number
... name Σ1..1stringStudy Name
... description 1..1stringThe study's description
... disease_focus 0..*CodingDisease or focus of the study
... attribution 0..*stringAttribution
... weblinks 0..*stringWeb Links
... study_design 0..*CodingStudy Design
... study_type 0..*CodingStudy Type
... citation 0..*stringCitation(s) associated with this study
... study_documents 0..*stringStudy Documents

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. common-data-model-research-study 0..*BaseCDM Research Study
Instances of this logical model are not marked to be the target of a Reference
... consortium Σ0..1stringConsortium
... accession Σ1..1stringStudy Accession Number
... name Σ1..1stringStudy Name
... description 1..1stringThe study's description
... disease_focus 0..*CodingDisease or focus of the study
... attribution 0..*stringAttribution
... weblinks 0..*stringWeb Links
... study_design 0..*CodingStudy Design
... study_type 0..*CodingStudy Type
... citation 0..*stringCitation(s) associated with this study
... study_documents 0..*stringStudy Documents

doco Documentation for this format

This structure is derived from Base

Summary

Mandatory: 0 element (3 nested mandatory elements)

Differential View

This structure is derived from Base

NameFlagsCard.TypeDescription & Constraintsdoco
.. common-data-model-research-study 0..*BaseCDM Research Study
Instances of this logical model are not marked to be the target of a Reference
... consortium Σ0..1stringConsortium
... accession Σ1..1stringStudy Accession Number
... name Σ1..1stringStudy Name
... description 1..1stringThe study's description
... disease_focus 0..*CodingDisease or focus of the study
... attribution 0..*stringAttribution
... weblinks 0..*stringWeb Links
... study_design 0..*CodingStudy Design
... study_type 0..*CodingStudy Type
... citation 0..*stringCitation(s) associated with this study
... study_documents 0..*stringStudy Documents

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. common-data-model-research-study 0..*BaseCDM Research Study
Instances of this logical model are not marked to be the target of a Reference
... consortium Σ0..1stringConsortium
... accession Σ1..1stringStudy Accession Number
... name Σ1..1stringStudy Name
... description 1..1stringThe study's description
... disease_focus 0..*CodingDisease or focus of the study
... attribution 0..*stringAttribution
... weblinks 0..*stringWeb Links
... study_design 0..*CodingStudy Design
... study_type 0..*CodingStudy Type
... citation 0..*stringCitation(s) associated with this study
... study_documents 0..*stringStudy Documents

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. common-data-model-research-study 0..*BaseCDM Research Study
Instances of this logical model are not marked to be the target of a Reference
... consortium Σ0..1stringConsortium
... accession Σ1..1stringStudy Accession Number
... name Σ1..1stringStudy Name
... description 1..1stringThe study's description
... disease_focus 0..*CodingDisease or focus of the study
... attribution 0..*stringAttribution
... weblinks 0..*stringWeb Links
... study_design 0..*CodingStudy Design
... study_type 0..*CodingStudy Type
... citation 0..*stringCitation(s) associated with this study
... study_documents 0..*stringStudy Documents

doco Documentation for this format

This structure is derived from Base

Summary

Mandatory: 0 element (3 nested mandatory elements)

 

Other representations of profile: CSV, Excel

Notes:

Identifiers (Accession IDs, Acronyms, etc)

Identifiers serve to allow researchers to identify exactly which study is being described. This includes Accession Numbers for studies where the data has been submitted to a public database such as dbGaP. Other identifiers may include IDs that differentiate the study from consortium peer studies and … The identifiers may include:

  • dbGaP
  • Acronyms

For the purposes of this model, we’ll refer to all of these as accession ids.

Name and description

Each study will have a name as well as a detailed description.

Study Design and Study Type

Study Focus

Studies will have one or more focus which may be either a disease or a phenotype.

Studies may be comprised of substudies

These sub-studies may be related to data-use restrictions such as how participants were consented or the types of data that were captured for study.

Organizational Membership

A study may be a member of an organization, such as a consortium.