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Tools

ResearchStudy — Clinical research study

The formal protocol of a clinical study in FHIR: randomised trial, observational study, registry, meta-analysis, translational research. Bridge to ClinicalTrials.gov, EU CTR, FDA.

Purpose of the resource

ResearchStudy models the protocol and status of a study: primary purpose (treatment, prevention, screening, diagnostic, supportive-care, observational), phase (I, II, III, IV), design (RCT, crossover, single-arm, cohort), inclusion criteria via EvidenceVariable, participating sites, sponsor, national and international identifiers (NCT, EudraCT, JapicCTI…).

Key fields

FieldTypeCardinalityRole
urluri0..1Canonical URL.
identifierIdentifier[]0..*NCT, EudraCT, JapicCTI, internal identifier.
titlestring0..1Scientific title.
labelBackboneElement[]0..*Alternative titles (acronym, public).
protocolReference(PlanDefinition)[]0..*Associated protocols.
partOfReference(ResearchStudy)[]0..*Parent study (programme).
relatesToBackboneElement[]0..*Links to other ResearchStudies.
datedateTime0..1Registration date.
statuscode1..1active | 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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn.
primaryPurposeTypeCodeableConcept0..1Primary purpose.
phaseCodeableConcept0..1Clinical phase.
studyDesignCodeableConcept[]0..*Design.
focusCodeableReference[]0..*Study focus (Condition, Medication…).
conditionCodeableConcept[]0..*Conditions studied.
keywordCodeableConcept[]0..*Keywords.
regionCodeableConcept[]0..*Regions concerned.
periodPeriod0..1Study period.
siteReference(Location | ResearchStudy | Organization)[]0..*Participating sites.
recruitmentBackboneElement0..1Recruitment state (target, actual, eligibility).
comparisonGroupBackboneElement[]0..*Study arms.
objectiveBackboneElement[]0..*Primary/secondary objectives.
outcomeMeasureBackboneElement[]0..*Outcome measures.
resultReference(EvidenceReport | Citation | DiagnosticReport)[]0..*Published results.

JSON example

json researchstudy-example.json 
{
  "resourceType": "ResearchStudy",
  "id": "example-trial-001",
  "url": "http://example.org/ResearchStudy/example-trial-001",
  "identifier": [{
    "system": "https://clinicaltrials.gov",
    "value": "NCT05000001"
  }],
  "title": "Apixaban versus Warfarin in Non-Valvular Atrial Fibrillation",
  "status": "active",
  "primaryPurposeType": {
    "coding": [{
      "system": "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type",
      "code": "treatment"
    }]
  },
  "phase": {
    "coding": [{
      "system": "http://terminology.hl7.org/CodeSystem/research-study-phase",
      "code": "phase-3"
    }]
  },
  "studyDesign": [{
    "coding": [{
      "system": "http://terminology.hl7.org/CodeSystem/research-study-design",
      "code": "randomized-controlled-trial"
    }]
  }],
  "period": {
    "start": "2026-05-15",
    "end": "2030-12-31"
  }
}

Regulatory registries

  • ClinicalTrials.gov — US registry (NCT number).
  • EU CTR — unified European registry (EUCTR number) succeeding EudraCT.
  • JapicCTI — Japan Pharmaceutical Information Center.
  • National authorities — country-level clinical trial databases.
  • WHO ICTRP — global registry.

Common pitfalls

  • Identifier without system — cannot locate the study.
  • Status out of sync — status should mirror ClinicalTrials.gov.
  • Focus vs condition confusion — focus is broader.