Medidata Rave Clinical Trial Subject

{
  "$schema": "https://json-schema.org/draft/2020-12/schema",
  "$id": "https://raw.githubusercontent.com/api-evangelist/medidata/refs/heads/main/json-schema/medidata-subject-schema.json",
  "title": "Medidata Rave Clinical Trial Subject",
  "description": "A trial subject enrolled in a Medidata Rave clinical study",
  "type": "object",
  "required": ["subjectKey", "siteID", "status"],
  "properties": {
    "subjectKey": {
      "type": "string",
      "description": "Unique subject identifier within the study (may be auto-generated)"
    },
    "siteID": {
      "type": "string",
      "description": "ID of the investigator site where the subject is enrolled"
    },
    "siteName": {
      "type": "string"
    },
    "status": {
      "type": "string",
      "enum": ["Active", "Inactive", "Screened", "Failed", "Randomized", "Completed", "Withdrawn"],
      "description": "Current enrollment status of the subject"
    },
    "enrollmentDate": {
      "type": ["string", "null"],
      "format": "date"
    },
    "screeningDate": {
      "type": ["string", "null"],
      "format": "date"
    },
    "initials": {
      "type": "string",
      "maxLength": 10,
      "description": "Subject initials (used in place of PII)"
    },
    "studyOID": {
      "type": "string",
      "description": "Parent study Object Identifier"
    },
    "events": {
      "type": "array",
      "description": "Clinical events (visits) for this subject",
      "items": {
        "$ref": "#/$defs/ClinicalEvent"
      }
    }
  },
  "$defs": {
    "ClinicalEvent": {
      "type": "object",
      "required": ["eventOID"],
      "properties": {
        "eventOID": {
          "type": "string",
          "description": "Event Object Identifier (visit definition OID)"
        },
        "eventName": {
          "type": "string"
        },
        "eventDate": {
          "type": ["string", "null"],
          "format": "date"
        },
        "repeatKey": {
          "type": ["string", "null"],
          "description": "Repeat key for recurring events"
        },
        "forms": {
          "type": "array",
          "items": {
            "$ref": "#/$defs/CRFForm"
          }
        }
      }
    },
    "CRFForm": {
      "type": "object",
      "required": ["formOID"],
      "properties": {
        "formOID": {
          "type": "string"
        },
        "formName": {
          "type": "string"
        },
        "fields": {
          "type": "array",
          "items": {
            "$ref": "#/$defs/CRFField"
          }
        }
      }
    },
    "CRFField": {
      "type": "object",
      "required": ["fieldOID"],
      "properties": {
        "fieldOID": {
          "type": "string"
        },
        "value": {
          "type": ["string", "null"]
        },
        "status": {
          "type": "string",
          "enum": ["NotStarted", "Saved", "Incomplete", "Complete", "Verified", "Signed", "Frozen", "Locked"]
        },
        "dataEntryDateTime": {
          "type": ["string", "null"],
          "format": "date-time"
        },
        "enteredBy": {
          "type": "string"
        }
      }
    }
  }
}