ResearchStudy
ResearchStudy
draftResource44 elementsv4.0.1
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.
Metadata
hl7.org/fhir- Canonical URL
- http://hl7.org/fhir/StructureDefinition/ResearchStudy
- ID
- ResearchStudy
- Type
- Base Definition
- Derivation
- specialization
- Publisher
- Health Level Seven International (Biomedical Research and Regulation)
- Version
- 4.0.1
| Path | Card. | Type | Description |
|---|---|---|---|
ResearchStudy | 0..* | Investigation to increase healthcare-related patient-independent knowledge | |
id | 0..1 | string | Logical id of this artifact |
meta | 0..1 | Metadata about the resource | |
implicitRules | 0..1 | uri | A set of rules under which this content was created |
language | 0..1 | code | Language of the resource contentpreferred: languages |
text | 0..1 | Text summary of the resource, for human interpretation | |
contained | 0..* | Resource | Contained, inline Resources |
extension | 0..* | Additional content defined by implementations | |
modifierExtension | 0..* | Extensions that cannot be ignored | |
identifier | 0..* | Business Identifier for study | |
title | 0..1 | string | Name for this study |
protocol | 0..* | Steps followed in executing study | |
partOf | 0..* | Part of larger study | |
status | 1..1 | code | 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 | withdrawnrequired: research-study-status |
primaryPurposeType | 0..1 | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibilityextensible: research-study-prim-purp-type | |
phase | 0..1 | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4example: research-study-phase | |
category | 0..* | Classifications for the study | |
focus | 0..* | Drugs, devices, etc. under study | |
condition | 0..* | Condition being studiedexample: condition-code | |
contact | 0..* | Contact details for the study | |
relatedArtifact | 0..* | References and dependencies | |
keyword | 0..* | Used to search for the study | |
location | 0..* | Geographic region(s) for studyextensible: jurisdiction | |
description | 0..1 | markdown | What this is study doing |
enrollment | 0..* | Inclusion & exclusion criteria | |
period | 0..1 | When the study began and ended | |
sponsor | 0..1 | Organization that initiates and is legally responsible for the study | |
principalInvestigator | 0..1 | Researcher who oversees multiple aspects of the study | |
site | 0..* | Facility where study activities are conducted | |
reasonStopped | 0..1 | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-designexample: research-study-reason-stopped | |
note | 0..* | Comments made about the study | |
arm | 0..* | BackboneElement | Defined path through the study for a subject |
objective | 0..* | BackboneElement | A goal for the study |