ResearchStudy
A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
These interaction paths describe standard FHIR R4 patterns. Availability can depend on the API capabilities enabled for your Ovok project.
| Interaction | Method | Path |
|---|---|---|
| Read | GET | /fhir/R4/ResearchStudy/[id] |
| Vread | GET | /fhir/R4/ResearchStudy/[id]/_history/[vid] |
| Update | PUT | /fhir/R4/ResearchStudy/[id] |
| Patch | PATCH | /fhir/R4/ResearchStudy/[id] |
| Delete | DELETE | /fhir/R4/ResearchStudy/[id] |
| Create | POST | /fhir/R4/ResearchStudy |
| Search | GET | /fhir/R4/ResearchStudy |
| History | GET | /fhir/R4/ResearchStudy/[id]/_history |
Top-level elements
| Element | Type | Cardinality | Description |
|---|---|---|---|
id | string | 0..1 | Logical id of this artifact |
meta | Meta | 0..1 | Metadata about the resource |
implicitRules | uri | 0..1 | A set of rules under which this content was created |
language | code | 0..1 | Language of the resource content |
text | Narrative | 0..1 | Text summary of the resource, for human interpretation |
contained | Resource | 0..* | Contained, inline Resources |
extension | Extension | 0..* | Additional content defined by implementations |
modifierExtension | Extension | 0..* | Extensions that cannot be ignored |
identifier | Identifier | 0..* | Business Identifier for study |
title | string | 0..1 | Name for this study |
protocol | Reference | 0..* | Steps followed in executing study |
partOf | Reference | 0..* | Part of larger study |
status | code | 1..1 | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn |
primaryPurposeType | CodeableConcept | 0..1 | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility |
phase | CodeableConcept | 0..1 | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 |
category | CodeableConcept | 0..* | Classifications for the study |
focus | CodeableConcept | 0..* | Drugs, devices, etc. under study |
condition | CodeableConcept | 0..* | Condition being studied |
contact | ContactDetail | 0..* | Contact details for the study |
relatedArtifact | RelatedArtifact | 0..* | References and dependencies |
keyword | CodeableConcept | 0..* | Used to search for the study |
location | CodeableConcept | 0..* | Geographic region(s) for study |
description | markdown | 0..1 | What this is study doing |
enrollment | Reference | 0..* | Inclusion & exclusion criteria |
period | Period | 0..1 | When the study began and ended |
sponsor | Reference | 0..1 | Organization that initiates and is legally responsible for the study |
principalInvestigator | Reference | 0..1 | Researcher who oversees multiple aspects of the study |
site | Reference | 0..* | Facility where study activities are conducted |
reasonStopped | CodeableConcept | 0..1 | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design |
note | Annotation | 0..* | Comments made about the study |
arm | BackboneElement | 0..* | Defined path through the study for a subject |
objective | BackboneElement | 0..* | A goal for the study |
Resource-specific search parameters
| Parameter | Type | Description |
|---|---|---|
category | token | Classifications for the study |
date | date | When the study began and ended |
focus | token | Drugs, devices, etc. under study |
identifier | token | Business Identifier for study |
keyword | token | Used to search for the study |
location | token | Geographic region(s) for study |
partof | reference | Part of larger study |
principalinvestigator | reference | Researcher who oversees multiple aspects of the study |
protocol | reference | Steps followed in executing study |
site | reference | Facility where study activities are conducted |
sponsor | reference | Organization that initiates and is legally responsible for the study |
status | token | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn |
title | string | Name for this study |
Reference
Official FHIR R4 spec: ResearchStudy.
Maturity: Trial Use 1 (FMM 1).