medidata Clinical Data API

openapi: 3.1.0
info:
  title: Medidata Rave EDC REST Audit Clinical Data API
  description: Medidata Rave provides electronic data capture (EDC) APIs for clinical trial data collection and management. APIs enable access to study designs, case report forms, patient data, queries, and audit trails for clinical research organizations and pharmaceutical companies.
  version: 1.0.0
  contact:
    name: Medidata Support
    url: https://www.medidata.com/support
  license:
    name: Proprietary
    url: https://www.medidata.com/terms
servers:
- url: https://{tenant}.medidata.com/RaveWebServices/studies
  variables:
    tenant:
      default: medidatatrials
      description: Your Medidata Rave instance subdomain
- url: https://developer.medidata.com/api/v2
  description: Medidata Developer API v2
security:
- BasicAuth: []
- OAuth2: []
tags:
- name: Clinical Data
  description: CRF data entry and retrieval
paths:
  /{studyOID}/Subjects/{subjectKey}/ClinicalData:
    get:
      operationId: getSubjectClinicalData
      summary: Get clinical data (CRF data) for a subject
      description: Retrieve all clinical data (case report form field values) for a subject across all visit events and CRF pages.
      tags:
      - Clinical Data
      parameters:
      - name: studyOID
        in: path
        required: true
        schema:
          type: string
      - name: subjectKey
        in: path
        required: true
        schema:
          type: string
      - name: formOID
        in: query
        schema:
          type: string
        description: Filter to a specific form OID
      - name: EventRepeatKey
        in: query
        schema:
          type: string
      responses:
        '200':
          description: Subject clinical data
          content:
            application/json:
              schema:
                $ref: '#/components/schemas/ClinicalDataResponse'
    post:
      operationId: submitClinicalData
      summary: Submit clinical data for a subject
      description: Submit or update CRF field values for a subject. Supports ODM-compliant clinical data XML or JSON submission.
      tags:
      - Clinical Data
      parameters:
      - name: studyOID
        in: path
        required: true
        schema:
          type: string
      - name: subjectKey
        in: path
        required: true
        schema:
          type: string
      requestBody:
        required: true
        content:
          application/json:
            schema:
              $ref: '#/components/schemas/ClinicalDataSubmission'
      responses:
        '200':
          description: Data submitted successfully
          content:
            application/json:
              schema:
                $ref: '#/components/schemas/SubmissionResponse'
components:
  schemas:
    ClinicalDataResponse:
      type: object
      properties:
        subjectKey:
          type: string
        studyOID:
          type: string
        events:
          type: array
          items:
            $ref: '#/components/schemas/ClinicalDataEvent'
    SubmissionResponse:
      type: object
      properties:
        status:
          type: string
          enum:
          - Success
          - Partial
          - Failed
        message:
          type: string
        subjectKey:
          type: string
        warnings:
          type: array
          items:
            type: string
    ClinicalDataEvent:
      type: object
      properties:
        eventOID:
          type: string
        eventName:
          type: string
        eventDate:
          type: string
          format: date
        repeatKey:
          type: string
        forms:
          type: array
          items:
            $ref: '#/components/schemas/CRFForm'
    CRFForm:
      type: object
      properties:
        formOID:
          type: string
        formName:
          type: string
        fields:
          type: array
          items:
            $ref: '#/components/schemas/CRFField'
    ClinicalDataSubmission:
      type: object
      required:
      - events
      properties:
        events:
          type: array
          items:
            type: object
            required:
            - eventOID
            - forms
            properties:
              eventOID:
                type: string
              eventDate:
                type: string
                format: date
              repeatKey:
                type: string
              forms:
                type: array
                items:
                  type: object
                  required:
                  - formOID
                  - fields
                  properties:
                    formOID:
                      type: string
                    fields:
                      type: array
                      items:
                        type: object
                        required:
                        - fieldOID
                        - value
                        properties:
                          fieldOID:
                            type: string
                          value:
                            type: string
    CRFField:
      type: object
      properties:
        fieldOID:
          type: string
        value:
          type: string
        status:
          type: string
          enum:
          - NotStarted
          - Saved
          - Incomplete
          - Complete
          - Verified
          - Signed
          - Frozen
          - Locked
        dataEntryDateTime:
          type: string
          format: date-time
        enteredBy:
          type: string
  securitySchemes:
    BasicAuth:
      type: http
      scheme: basic
      description: Medidata Rave username and password
    OAuth2:
      type: oauth2
      flows:
        clientCredentials:
          tokenUrl: https://identity.medidata.com/connect/token
          scopes:
            rave.read: Read access to Rave study data
            rave.write: Write access to Rave study data
externalDocs:
  description: Medidata Developer Documentation
  url: https://www.medidata.com/