NCPI FHIR Implementation Guide - Local Development build (v0.2.0). See the Directory of published versions
Resource Profile: NCPI Research Study
| Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/ncpi-research-study | Version: 0.2.0 | |||
| Draft as of 2022-12-09 | Computable Name: NcpiResearchStudy | |||
The NCPI Research Study is based upon the core FHIR ResearchStudy resource and shall act as the umbrella under which all study resources can ultimately be found. For the purposes of interoperability, some restrictions have been made to enforce a common mechanism for describing enrollment and provide a simple means for summarizing subject count and consent group membership.
Added Profile Restrictions
In order to ensure consistency across all NCPI research studies represented in FHIR, there are some additional requirements that are to be enforced:
The following requirements are true for all NCPI Research Studies:
- enrollment must contain 1 or more reference
- enrollment must only reference NCPI StudyGroup resources
- category must contain the Coding from NCPI StudyCohort
Recommended Practices
In order to support interoperability, whenever possible, the NCPI Research Study resource should have one or more Codings provided for the Study’s condition property indicating the disease or phenotype’s that were interrogated during the study’s execution.
Usage:
- Refer to this Resource Profile:
- Examples for this Resource Profile: ResearchStudy/ncpi-research-study-01
Formal Views of Profile Content
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ResearchStudy
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ResearchStudy | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
  category | ||||
  coding | 0..* | Coding | Code defined by a terminology system Required Pattern: At least the following | |
   system | 1..1 | uri | Identity of the terminology system Fixed Value: https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: StudyCohort | |
 display | 1..1 | string | Representation defined by the system Fixed Value: Study Cohort | |
 enrollment | 1..* | Reference(NCPI Study Group) | Inclusion & exclusion criteria | |
| Documentation for this format | ||||
Other representations of profile: CSV, Excel, Schematron
Notes:
Each NCPI Research must have at least one NCPI Study Group which must, at the very least indicate the total number of patients enrolled at the time the data was loaded into FHIR. Additional Study Groups can be present indicating relevant groupings of subjects, such as for different consent groups.
Practices for Summary Only Resources
For Studies loaded into Summary Only FHIR servers, the Study’s Study Group resources must have the quantity. This promotes findability by enabling researches without current access to the study’s row-level data to get basic study details including the different subject counts.
For studies that exist alongside row-level data, the Study’s Study Group resources should have each corresponding Patient referenced in the Group’s members array.