ClinicalTrial

{
  "$schema": "https://json-schema.org/draft/2020-12/schema",
  "$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        "Withdrawn",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"]
}