Data standards & interoperability
CDISC makes trial data submittable to regulators. FHIR makes it exchangeable with hospital systems and national health infrastructure. A trial participant at AIIA is also a patient in AIIA's 200-bed hospital, so both directions are needed.
Resource browser
Six R4 resources cover the trial data model
ResearchStudy — example instance
Generated from study CTRI/2026/XX/SYN001
FHIR R4 · 4.0.1meta.tag = HTEST (test health data)identifier.system = https://ctri.nic.in
ResearchStudy.json
{
"resourceType": "ResearchStudy",
"id": "aiia-san-001",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
]
},
"identifier": [
{
"system": "https://ctri.nic.in",
"value": "CTRI/2026/XX/SYN001",
"assigner": {
"display": "Clinical Trials Registry – India (ICMR-NIMS)"
}
}
],
"title": "Efficacy of Ashwagandha Ghrita in Sandhivata (osteoarthritis of the knee)",
"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": [
{
"text": "Randomised, parallel group, open label"
}
],
"condition": [
{
"text": "Osteoarthritis of knee (Sandhivata)"
}
],
"sponsor": {
"reference": "Organization/aiia",
"display": "All India Institute of Ayurveda"
},
"principalInvestigator": {
"reference": "Practitioner/san-pi",
"display": "Dr. A. Krishnamurthy"
},
"site": [
{
"reference": "Location/aiia-new-delhi",
"display": "All India Institute of Ayurveda, New Delhi"
},
{
"reference": "Location/nia-jaipur",
"display": "National Institute of Ayurveda"
}
],
"enrollment": [
{
"reference": "Group/aiia-san-001-eligibility",
"display": "Inclusion / exclusion criteria group"
}
],
"period": {
"start": "2025-08-03"
},
"description": "A randomised, parallel-group, open-label comparative clinical trial of Ashwagandha Ghrita versus standard Ayurvedic care in Sandhivata (osteoarthritis of the knee joint)"
}Generated live from the record shown elsewhere in this app. The identifier, USUBJID, onset timestamps and outcomes above are the same values rendered on the portfolio, study detail and pharmacovigilance pages — cross-check any of them.
Study bundle
A collection Bundle for SAN — the study, three participants with their consents, and its safety events
SAN-bundle.json
{
"resourceType": "Bundle",
"id": "aiia-san-001-bundle",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
]
},
"type": "collection",
"timestamp": "2026-09-07T09:00:00+05:30",
"total": 12,
"entry": [
{
"fullUrl": "urn:uuid:aiia-san-001",
"resource": {
"resourceType": "ResearchStudy",
"id": "aiia-san-001",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
]
},
"identifier": [
{
"system": "https://ctri.nic.in",
"value": "CTRI/2026/XX/SYN001",
"assigner": {
"display": "Clinical Trials Registry – India (ICMR-NIMS)"
}
}
],
"title": "Efficacy of Ashwagandha Ghrita in Sandhivata (osteoarthritis of the knee)",
"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": [
{
"text": "Randomised, parallel group, open label"
}
],
"condition": [
{
"text": "Osteoarthritis of knee (Sandhivata)"
}
],
"sponsor": {
"reference": "Organization/aiia",
"display": "All India Institute of Ayurveda"
},
"principalInvestigator": {
"reference": "Practitioner/san-pi",
"display": "Dr. A. Krishnamurthy"
},
"site": [
{
"reference": "Location/aiia-new-delhi",
"display": "All India Institute of Ayurveda, New Delhi"
},
{
"reference": "Location/nia-jaipur",
"display": "National Institute of Ayurveda"
}
],
"enrollment": [
{
"reference": "Group/aiia-san-001-eligibility",
"display": "Inclusion / exclusion criteria group"
}
],
"period": {
"start": "2025-08-03"
},
"description": "A randomised, parallel-group, open-label comparative clinical trial of Ashwagandha Ghrita versus standard Ayurvedic care in Sandhivata (osteoarthritis of the knee joint)"
}
},
{
"fullUrl": "urn:uuid:aiia-san-del-001",
"resource": {
"resourceType": "Patient",
"id": "aiia-san-del-001",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
],
"security": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ObservationValue",
"code": "ANONYED",
"display": "anonymized"
}
]
},
"identifier": [
{
"system": "https://aiia.gov.in/ctms/usubjid",
"value": "AIIA-SAN-DEL-001"
},
{
"system": "https://healthid.abdm.gov.in",
"value": "**** **** **** (ABHA not linked in demo)"
}
],
"active": true,
"gender": "female",
"birthDate": "1960",
"managingOrganization": {
"reference": "Organization/aiia",
"display": "All India Institute of Ayurveda"
}
}
},
{
"fullUrl": "urn:uuid:aiia-san-del-001-rs",
"resource": {
"resourceType": "ResearchSubject",
"id": "aiia-san-del-001",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
]
},
"identifier": [
{
"system": "https://aiia.gov.in/ctms/usubjid",
"value": "AIIA-SAN-DEL-001"
}
],
"status": "on-study-intervention",
"period": {
"start": "2026-06-20"
},
"study": {
"reference": "ResearchStudy/aiia-san-001"
},
"individual": {
"reference": "Patient/aiia-san-del-001"
},
"assignedArm": "Comparator arm",
"actualArm": "Comparator arm",
"consent": {
"reference": "Consent/aiia-san-del-001-icf"
}
}
},
{
"fullUrl": "urn:uuid:aiia-san-del-001-icf",
"resource": {
"resourceType": "Consent",
"id": "aiia-san-del-001-icf",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
]
},
"identifier": [
{
"system": "https://aiia.gov.in/ctms/consent",
"value": "AIIA-SAN-DEL-001-v2.1"
}
],
"status": "active",
"scope": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/consentscope",
"code": "research"
}
]
},
"category": [
{
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/consentcategorycodes",
"code": "research"
}
],
"text": "Informed consent document v2.1"
}
],
"patient": {
"reference": "Patient/aiia-san-del-001"
},
"dateTime": "2026-06-14T11:15:00+05:30",
"performer": [
{
"reference": "Patient/aiia-san-del-001",
"display": "Data Principal (participant)"
}
],
"policyRule": {
"text": "Digital Personal Data Protection Act 2023, read with the DPDP Rules notified 13 November 2025"
},
"provision": {
"type": "permit",
"period": {
"start": "2026-06-14"
},
"purpose": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HRESCH",
"display": "healthcare research"
}
],
"data": [
{
"meaning": "instance",
"reference": {
"reference": "ResearchStudy/aiia-san-001"
}
}
]
}
}
},
{
"fullUrl": "urn:uuid:aiia-san-jai-002",
"resource": {
"resourceType": "Patient",
"id": "aiia-san-jai-002",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
],
"security": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ObservationValue",
"code": "ANONYED",
"display": "anonymized"
}
]
},
"identifier": [
{
"system": "https://aiia.gov.in/ctms/usubjid",
"value": "AIIA-SAN-JAI-002"
},
{
"system": "https://healthid.abdm.gov.in",
"value": "**** **** **** (ABHA not linked in demo)"
}
],
"active": true,
"gender": "male",
"birthDate": "1994",
"managingOrganization": {
"reference": "Organization/aiia",
"display": "All India Institute of Ayurveda"
}
}
},
{
"fullUrl": "urn:uuid:aiia-san-jai-002-rs",
"resource": {
"resourceType": "ResearchSubject",
"id": "aiia-san-jai-002",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
]
},
"identifier": [
{
"system": "https://aiia.gov.in/ctms/usubjid",
"value": "AIIA-SAN-JAI-002"
}
],
"status": "on-study-intervention",
"period": {
"start": "2026-06-18"
},
"study": {
"reference": "ResearchStudy/aiia-san-001"
},
"individual": {
"reference": "Patient/aiia-san-jai-002"
},
"assignedArm": "Interventional arm",
"actualArm": "Interventional arm",
"consent": {
"reference": "Consent/aiia-san-jai-002-icf"
}
}
},
{
"fullUrl": "urn:uuid:aiia-san-jai-002-icf",
"resource": {
"resourceType": "Consent",
"id": "aiia-san-jai-002-icf",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
]
},
"identifier": [
{
"system": "https://aiia.gov.in/ctms/consent",
"value": "AIIA-SAN-JAI-002-v2.1"
}
],
"status": "active",
"scope": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/consentscope",
"code": "research"
}
]
},
"category": [
{
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/consentcategorycodes",
"code": "research"
}
],
"text": "Informed consent document v2.1"
}
],
"patient": {
"reference": "Patient/aiia-san-jai-002"
},
"dateTime": "2026-06-12T11:15:00+05:30",
"performer": [
{
"reference": "Patient/aiia-san-jai-002",
"display": "Data Principal (participant)"
}
],
"policyRule": {
"text": "Digital Personal Data Protection Act 2023, read with the DPDP Rules notified 13 November 2025"
},
"provision": {
"type": "permit",
"period": {
"start": "2026-06-12"
},
"purpose": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HRESCH",
"display": "healthcare research"
}
],
"data": [
{
"meaning": "instance",
"reference": {
"reference": "ResearchStudy/aiia-san-001"
}
}
]
}
}
},
{
"fullUrl": "urn:uuid:aiia-san-del-003",
"resource": {
"resourceType": "Patient",
"id": "aiia-san-del-003",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
],
"security": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ObservationValue",
"code": "ANONYED",
"display": "anonymized"
}
]
},
"identifier": [
{
"system": "https://aiia.gov.in/ctms/usubjid",
"value": "AIIA-SAN-DEL-003"
},
{
"system": "https://healthid.abdm.gov.in",
"value": "**** **** **** (ABHA not linked in demo)"
}
],
"active": true,
"gender": "female",
"birthDate": "2002",
"managingOrganization": {
"reference": "Organization/aiia",
"display": "All India Institute of Ayurveda"
}
}
},
{
"fullUrl": "urn:uuid:aiia-san-del-003-rs",
"resource": {
"resourceType": "ResearchSubject",
"id": "aiia-san-del-003",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
]
},
"identifier": [
{
"system": "https://aiia.gov.in/ctms/usubjid",
"value": "AIIA-SAN-DEL-003"
}
],
"status": "on-study",
"period": {
"start": "2026-04-10"
},
"study": {
"reference": "ResearchStudy/aiia-san-001"
},
"individual": {
"reference": "Patient/aiia-san-del-003"
},
"assignedArm": "Comparator arm",
"actualArm": "Comparator arm",
"consent": {
"reference": "Consent/aiia-san-del-003-icf"
}
}
},
{
"fullUrl": "urn:uuid:aiia-san-del-003-icf",
"resource": {
"resourceType": "Consent",
"id": "aiia-san-del-003-icf",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
]
},
"identifier": [
{
"system": "https://aiia.gov.in/ctms/consent",
"value": "AIIA-SAN-DEL-003-v2.1"
}
],
"status": "active",
"scope": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/consentscope",
"code": "research"
}
]
},
"category": [
{
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/consentcategorycodes",
"code": "research"
}
],
"text": "Informed consent document v2.1"
}
],
"patient": {
"reference": "Patient/aiia-san-del-003"
},
"dateTime": "2026-04-05T11:15:00+05:30",
"performer": [
{
"reference": "Patient/aiia-san-del-003",
"display": "Data Principal (participant)"
}
],
"policyRule": {
"text": "Digital Personal Data Protection Act 2023, read with the DPDP Rules notified 13 November 2025"
},
"provision": {
"type": "permit",
"period": {
"start": "2026-04-05"
},
"purpose": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HRESCH",
"display": "healthcare research"
}
],
"data": [
{
"meaning": "instance",
"reference": {
"reference": "ResearchStudy/aiia-san-001"
}
}
]
}
}
},
{
"fullUrl": "urn:uuid:sae-001",
"resource": {
"resourceType": "AdverseEvent",
"id": "sae-001",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
],
"profile": [
"http://hl7.org/fhir/uv/ae-research-backport/StructureDefinition/adverseevent-clinical-research"
]
},
"extension": [
{
"url": "http://hl7.org/fhir/uv/ae-research-backport/StructureDefinition/adverseevent-seriousness-criteria",
"valueCodeableConcept": {
"coding": [
{
"system": "https://aiia.gov.in/ctms/CodeSystem/sdtm-seriousness-flag",
"code": "AESHOSP"
}
],
"text": "AESHOSP"
}
},
{
"url": "http://hl7.org/fhir/uv/ae-research-backport/StructureDefinition/adverseevent-caused-subject-to-discontinue-study",
"valueBoolean": true
},
{
"url": "http://hl7.org/fhir/uv/ae-research-backport/StructureDefinition/adverseevent-grade",
"valueCodeableConcept": {
"text": "SEVERE"
}
}
],
"identifier": {
"system": "https://npvcc.aiia.gov.in",
"value": "SAE-001"
},
"actuality": "actual",
"category": [
{
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-category",
"code": "product-use-error"
}
]
}
],
"event": {
"coding": [
{
"system": "https://aiia.gov.in/ctms/CodeSystem/illustrative-ae-terms",
"code": "hepatic-enzyme-increased",
"display": "Hepatic enzyme increased"
}
],
"text": "SGPT and SGOT raised on routine week-8 bloods, patient admitted for observation"
},
"subject": {
"reference": "Patient/aiia-san-del-007",
"display": "AIIA-SAN-DEL-007"
},
"date": "2026-09-06T11:00:00.000Z",
"seriousness": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
"code": "serious"
}
]
},
"severity": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
"code": "severe"
}
]
},
"outcome": {
"text": "NOT RECOVERED/NOT RESOLVED"
},
"recorder": {
"display": "Dr. A. Krishnamurthy"
},
"suspectEntity": [
{
"instance": {
"display": "Ashwagandha Ghrita 10 g twice daily, 12 weeks — WHODrug coding attaches here in production"
},
"causality": [
{
"assessment": {
"text": "Possible"
},
"productRelatedness": "Possible",
"method": {
"text": "WHO-UMC"
}
}
]
}
],
"study": [
{
"reference": "ResearchStudy/aiia-san-001"
}
]
}
},
{
"fullUrl": "urn:uuid:ae-002",
"resource": {
"resourceType": "AdverseEvent",
"id": "ae-002",
"meta": {
"tag": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
"code": "HTEST",
"display": "test health data"
}
],
"profile": [
"http://hl7.org/fhir/uv/ae-research-backport/StructureDefinition/adverseevent-clinical-research"
]
},
"extension": [
{
"url": "http://hl7.org/fhir/uv/ae-research-backport/StructureDefinition/adverseevent-caused-subject-to-discontinue-study",
"valueBoolean": false
},
{
"url": "http://hl7.org/fhir/uv/ae-research-backport/StructureDefinition/adverseevent-grade",
"valueCodeableConcept": {
"text": "MODERATE"
}
}
],
"identifier": {
"system": "https://npvcc.aiia.gov.in",
"value": "AE-002"
},
"actuality": "actual",
"category": [
{
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-category",
"code": "product-use-error"
}
]
}
],
"event": {
"coding": [
{
"system": "https://aiia.gov.in/ctms/CodeSystem/illustrative-ae-terms",
"code": "dyspepsia",
"display": "Dyspepsia"
}
],
"text": "burning sensation in chest at night"
},
"subject": {
"reference": "Patient/aiia-san-jai-009",
"display": "AIIA-SAN-JAI-009"
},
"date": "2026-08-16T17:00:00.000Z",
"seriousness": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
"code": "non-serious"
}
]
},
"severity": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
"code": "moderate"
}
]
},
"outcome": {
"text": "RECOVERED/RESOLVED"
},
"recorder": {
"display": "Dr. A. Krishnamurthy"
},
"suspectEntity": [
{
"instance": {
"display": "Ashwagandha Ghrita 10 g twice daily, 12 weeks — WHODrug coding attaches here in production"
},
"causality": [
{
"assessment": {
"text": "Possible"
},
"productRelatedness": "Possible",
"method": {
"text": "WHO-UMC"
}
}
]
}
],
"study": [
{
"reference": "ResearchStudy/aiia-san-001"
}
]
}
}
]
}