ResearchStudy

Overview

The ResearchStudy resource describes a clinical trial or research study. It captures study details including phases, objectives, eligibility criteria, and study arms.

FHIR R4 Specification

See the official HL7 specification: https://hl7.org/fhir/R4/researchstudy.html

Supported Fields

Field	Type	Description
id	string	Logical ID of the resource
meta	Meta	Resource metadata
identifier	Identifier[]	Business identifiers (NCT number, etc.)
title	string	Study title
protocol	Reference(PlanDefinition)[]	Study protocol
partOf	Reference(ResearchStudy)[]	Parent study
status	code	Study status
primaryPurposeType	CodeableConcept	Primary purpose
phase	CodeableConcept	Study phase
category	CodeableConcept[]	Study category
focus	CodeableConcept[]	Focus of study
condition	CodeableConcept[]	Conditions being studied
contact	ContactDetail[]	Study contacts
relatedArtifact	RelatedArtifact[]	Related documents
keyword	CodeableConcept[]	Keywords
location	CodeableConcept[]	Study locations
description	markdown	Study description
enrollment	Reference(Group)[]	Enrollment target
period	Period	Study period
sponsor	Reference(Organization)	Sponsor
principalInvestigator	Reference(Practitioner)	Lead investigator
site	Reference(Location)[]	Study sites
reasonStopped	CodeableConcept	Why stopped
note	Annotation[]	Notes
arm	BackboneElement[]	Study arms
objective	BackboneElement[]	Study objectives

Search Parameters

Parameter	Type	Description	Example
_id	token	Resource ID	_id=rs-001
identifier	token	Business identifier	identifier=NCT12345678
title	string	Study title	title=diabetes
status	token	Study status	status=active
phase	token	Study phase	phase=phase-3
category	token	Study category	category=interventional
condition	token	Condition studied	condition=44054006
date	date	Study period	date=ge2024-01-01
sponsor	reference	Sponsor	sponsor=Organization/456
principalinvestigator	reference	Lead investigator	principalinvestigator=Practitioner/789
site	reference	Study site	site=Location/loc-001

Examples

Create a ResearchStudy

curl -X POST http://localhost:8080/baseR4/ResearchStudy \
  -H "Content-Type: application/fhir+json" \
  -d '{
    "resourceType": "ResearchStudy",
    "identifier": [{
      "system": "http://clinicaltrials.gov",
      "value": "NCT12345678"
    }],
    "title": "Efficacy of Novel Diabetes Treatment in Adults",
    "status": "active",
    "primaryPurposeType": {
      "coding": [{
        "system": "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type",
        "code": "treatment",
        "display": "Treatment"
      }]
    },
    "phase": {
      "coding": [{
        "system": "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "code": "phase-3",
        "display": "Phase 3"
      }]
    },
    "category": [{
      "coding": [{
        "system": "http://terminology.hl7.org/CodeSystem/research-study-category",
        "code": "interventional",
        "display": "Interventional"
      }]
    }],
    "condition": [{
      "coding": [{
        "system": "http://snomed.info/sct",
        "code": "44054006",
        "display": "Type 2 diabetes mellitus"
      }]
    }],
    "description": "A Phase 3 interventional study investigating Type 2 diabetes mellitus.",
    "enrollment": [{
      "display": "Target enrollment: 250 participants"
    }],
    "period": {
      "start": "2024-01-01"
    },
    "sponsor": {
      "reference": "Organization/organization-001"
    },
    "principalInvestigator": {
      "reference": "Practitioner/practitioner-001"
    },
    "arm": [
      {
        "name": "Treatment Arm",
        "type": {
          "coding": [{
            "system": "http://terminology.hl7.org/CodeSystem/research-study-arm-type",
            "code": "experimental",
            "display": "Experimental"
          }]
        },
        "description": "Receives novel diabetes treatment"
      },
      {
        "name": "Control Arm",
        "type": {
          "coding": [{
            "system": "http://terminology.hl7.org/CodeSystem/research-study-arm-type",
            "code": "placebo-comparator",
            "display": "Placebo Comparator"
          }]
        },
        "description": "Receives placebo"
      }
    ],
    "objective": [{
      "name": "Primary Objective",
      "type": {
        "coding": [{
          "code": "primary",
          "display": "Primary"
        }]
      }
    }]
  }'

Search ResearchStudies

# By status
curl "http://localhost:8080/baseR4/ResearchStudy?status=active"

# By phase
curl "http://localhost:8080/baseR4/ResearchStudy?phase=phase-3"

# By condition
curl "http://localhost:8080/baseR4/ResearchStudy?condition=44054006"

# By identifier (NCT number)
curl "http://localhost:8080/baseR4/ResearchStudy?identifier=NCT12345678"

Status Codes

Code	Display	Description
active	Active	Study is active
administratively-completed	Administratively Completed	Study administratively completed
approved	Approved	Study approved
closed-to-accrual	Closed to Accrual	Not accepting new subjects
closed-to-accrual-and-intervention	Closed to Accrual and Intervention	Closed
completed	Completed	Study completed
disapproved	Disapproved	Study disapproved
in-review	In Review	Under review
temporarily-closed-to-accrual	Temporarily Closed	Temporarily not accepting
temporarily-closed-to-accrual-and-intervention	Temporarily Closed	Temporarily closed
withdrawn	Withdrawn	Study withdrawn

Study Phases

Code	Display
n-a	N/A
early-phase-1	Early Phase 1
phase-1	Phase 1
phase-1-phase-2	Phase 1/Phase 2
phase-2	Phase 2
phase-2-phase-3	Phase 2/Phase 3
phase-3	Phase 3
phase-4	Phase 4

Study Categories

Code	Display
interventional	Interventional
observational	Observational
expanded-access	Expanded Access

Primary Purpose Types

Code	Display
treatment	Treatment
prevention	Prevention
diagnostic	Diagnostic
supportive-care	Supportive Care
screening	Screening
health-services-research	Health Services Research
basic-science	Basic Science
device-feasibility	Device Feasibility

Arm Types

Code	Display
experimental	Experimental
active-comparator	Active Comparator
placebo-comparator	Placebo Comparator
sham-comparator	Sham Comparator
no-intervention	No Intervention
other	Other