Life Sciences · Schema

ClinicalTrial

A registered clinical trial study record, modeled on the harmonized fields used by ClinicalTrials.gov v2 and the EU Clinical Trials Information System (CTIS).

Life SciencesBiotechPharmaHealthcareClinical TrialsDrug InformationGenomicsBioinformaticsEHRFHIRLab Informatics

Properties

Name Type Description
nctId string ClinicalTrials.gov identifier in the form NCT followed by 8 digits.
euctNumber string EU Clinical Trial Number issued by CTIS, format YYYY-NNNNNN-NN-CC.
officialTitle string The full official scientific title of the study as registered.
briefTitle string Short public-facing title for the study.
status string Overall recruitment / lifecycle status.
phase array Clinical trial phase(s).
studyType string Primary study design type.
conditions array Conditions or diseases being studied (preferred terms; MeSH or MedDRA where available).
interventions array Interventions tested by the study.
sponsor object Lead organisation responsible for the trial.
locations array Investigative sites participating in the trial.
enrollment object
startDate string Date the first participant was or will be enrolled.
completionDate string Final date of data collection for the primary outcome measure.
primaryOutcomes array
eligibility object
url string Canonical registry URL for the trial.
View JSON Schema on GitHub

JSON Schema

clinical-trial-schema.json Raw ↑ 
{
  "$schema": "https://json-schema.org/draft/2020-12/schema",
  "$id": "https://raw.githubusercontent.com/api-evangelist/life-sciences/refs/heads/main/json-schema/clinical-trial-schema.json",
  "title": "ClinicalTrial",
  "description": "A registered clinical trial study record, modeled on the harmonized fields used by ClinicalTrials.gov v2 and the EU Clinical Trials Information System (CTIS).",
  "type": "object",
  "properties": {
    "nctId": {
      "type": "string",
      "description": "ClinicalTrials.gov identifier in the form NCT followed by 8 digits.",
      "pattern": "^NCT[0-9]{8}$",
      "example": "NCT04280705"
    },
    "euctNumber": {
      "type": "string",
      "description": "EU Clinical Trial Number issued by CTIS, format YYYY-NNNNNN-NN-CC.",
      "pattern": "^[0-9]{4}-[0-9]{6}-[0-9]{2}-[0-9]{2}$"
    },
    "officialTitle": {
      "type": "string",
      "description": "The full official scientific title of the study as registered."
    },
    "briefTitle": {
      "type": "string",
      "description": "Short public-facing title for the study."
    },
    "status": {
      "type": "string",
      "description": "Overall recruitment / lifecycle status.",
      "enum": [
        "Not yet recruiting",
        "Recruiting",
        "Enrolling by invitation",
        "Active, not recruiting",
        "Completed",
        "Suspended",
        "Terminated",
        "Withdrawn",
        "Unknown status"
      ]
    },
    "phase": {
      "type": "array",
      "description": "Clinical trial phase(s).",
      "items": {
        "type": "string",
        "enum": [
          "Early Phase 1",
          "Phase 1",
          "Phase 1/Phase 2",
          "Phase 2",
          "Phase 2/Phase 3",
          "Phase 3",
          "Phase 4",
          "Not Applicable"
        ]
      }
    },
    "studyType": {
      "type": "string",
      "enum": ["Interventional", "Observational", "Expanded Access"],
      "description": "Primary study design type."
    },
    "conditions": {
      "type": "array",
      "description": "Conditions or diseases being studied (preferred terms; MeSH or MedDRA where available).",
      "items": { "type": "string" },
      "example": ["COVID-19", "Type 2 Diabetes Mellitus"]
    },
    "interventions": {
      "type": "array",
      "description": "Interventions tested by the study.",
      "items": {
        "type": "object",
        "properties": {
          "type": {
            "type": "string",
            "enum": [
              "Drug",
              "Biological",
              "Device",
              "Procedure",
              "Behavioral",
              "Radiation",
              "Genetic",
              "Dietary Supplement",
              "Combination Product",
              "Diagnostic Test",
              "Other"
            ]
          },
          "name": { "type": "string" },
          "description": { "type": "string" }
        },
        "required": ["type", "name"]
      }
    },
    "sponsor": {
      "type": "object",
      "description": "Lead organisation responsible for the trial.",
      "properties": {
        "name": { "type": "string" },
        "class": {
          "type": "string",
          "enum": ["NIH", "Industry", "Academic", "U.S. Fed", "Other Gov", "Network", "Other"]
        }
      },
      "required": ["name"]
    },
    "locations": {
      "type": "array",
      "description": "Investigative sites participating in the trial.",
      "items": {
        "type": "object",
        "properties": {
          "facility": { "type": "string" },
          "city": { "type": "string" },
          "state": { "type": "string" },
          "country": { "type": "string" },
          "status": { "type": "string" }
        }
      }
    },
    "enrollment": {
      "type": "object",
      "properties": {
        "count": { "type": "integer", "minimum": 0 },
        "type": { "type": "string", "enum": ["Actual", "Anticipated", "Estimated"] }
      }
    },
    "startDate": {
      "type": "string",
      "format": "date",
      "description": "Date the first participant was or will be enrolled."
    },
    "completionDate": {
      "type": "string",
      "format": "date",
      "description": "Final date of data collection for the primary outcome measure."
    },
    "primaryOutcomes": {
      "type": "array",
      "items": {
        "type": "object",
        "properties": {
          "measure": { "type": "string" },
          "timeFrame": { "type": "string" },
          "description": { "type": "string" }
        },
        "required": ["measure"]
      }
    },
    "eligibility": {
      "type": "object",
      "properties": {
        "criteria": { "type": "string", "description": "Free-text inclusion/exclusion criteria." },
        "sex": { "type": "string", "enum": ["All", "Male", "Female"] },
        "minimumAge": { "type": "string", "example": "18 Years" },
        "maximumAge": { "type": "string", "example": "75 Years" },
        "healthyVolunteers": { "type": "boolean" }
      }
    },
    "url": {
      "type": "string",
      "format": "uri",
      "description": "Canonical registry URL for the trial."
    }
  },
  "required": ["nctId", "officialTitle", "status", "studyType"]
}