medidata Subjects API

openapi: 3.1.0
info:
  title: Medidata Rave EDC REST Audit Subjects 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: Subjects
  description: Trial subject enrollment and management
paths:
  /{studyOID}/Subjects:
    get:
      operationId: listSubjects
      summary: List subjects in a study
      description: Retrieve all subjects enrolled in the specified study. Returns subject key, site ID, status, and enrollment date.
      tags:
      - Subjects
      parameters:
      - name: studyOID
        in: path
        required: true
        schema:
          type: string
        description: Study OID (e.g., Mediflex(Dev))
      - name: Status
        in: query
        schema:
          type: string
          enum:
          - Active
          - Inactive
          - Screened
          - Failed
      - name: SiteID
        in: query
        schema:
          type: string
      responses:
        '200':
          description: Subject list
          content:
            application/json:
              schema:
                $ref: '#/components/schemas/SubjectListResponse'
        '401':
          $ref: '#/components/responses/Unauthorized'
        '404':
          $ref: '#/components/responses/NotFound'
    post:
      operationId: createSubject
      summary: Create or update a subject
      description: Enroll a new subject or update an existing subject's demographic data. Subject key must be provided if updating.
      tags:
      - Subjects
      parameters:
      - name: studyOID
        in: path
        required: true
        schema:
          type: string
      requestBody:
        required: true
        content:
          application/json:
            schema:
              $ref: '#/components/schemas/SubjectCreateRequest'
      responses:
        '200':
          description: Subject created or updated
          content:
            application/json:
              schema:
                $ref: '#/components/schemas/Subject'
        '400':
          $ref: '#/components/responses/BadRequest'
  /{studyOID}/Subjects/{subjectKey}:
    get:
      operationId: getSubject
      summary: Get subject details
      description: Retrieve full details of a single subject including all CRF data, events, and queries.
      tags:
      - Subjects
      parameters:
      - name: studyOID
        in: path
        required: true
        schema:
          type: string
      - name: subjectKey
        in: path
        required: true
        schema:
          type: string
      responses:
        '200':
          description: Subject details
          content:
            application/json:
              schema:
                $ref: '#/components/schemas/Subject'
        '404':
          $ref: '#/components/responses/NotFound'
components:
  schemas:
    SubjectCreateRequest:
      type: object
      required:
      - siteID
      properties:
        subjectKey:
          type: string
          description: Provide to update existing subject; omit to auto-assign
        siteID:
          type: string
        status:
          type: string
        screeningDate:
          type: string
          format: date
        initials:
          type: string
    SubjectListResponse:
      type: object
      properties:
        subjects:
          type: array
          items:
            $ref: '#/components/schemas/Subject'
        totalCount:
          type: integer
    Subject:
      type: object
      properties:
        subjectKey:
          type: string
          description: Unique subject identifier within the study
        siteID:
          type: string
        siteName:
          type: string
        status:
          type: string
          enum:
          - Active
          - Inactive
          - Screened
          - Failed
          - Randomized
          - Completed
          - Withdrawn
        enrollmentDate:
          type: string
          format: date
        screeningDate:
          type: string
          format: date
        initials:
          type: string
        studyOID:
          type: string
    ErrorResponse:
      type: object
      properties:
        ErrorCode:
          type: integer
        ErrorDescription:
          type: string
  responses:
    BadRequest:
      description: Invalid request
      content:
        application/json:
          schema:
            $ref: '#/components/schemas/ErrorResponse'
    Unauthorized:
      description: Authentication failed
      content:
        application/json:
          schema:
            $ref: '#/components/schemas/ErrorResponse'
    NotFound:
      description: Resource not found
      content:
        application/json:
          schema:
            $ref: '#/components/schemas/ErrorResponse'
  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/