medidata Audit API

openapi: 3.1.0
info:
  title: Medidata Rave EDC REST Audit 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: Audit
  description: Audit trail access for 21 CFR Part 11 compliance
paths:
  /{studyOID}/AuditRecords:
    get:
      operationId: getAuditRecords
      summary: Get audit trail records
      description: Retrieve audit trail records for data changes in the study. Provides a 21 CFR Part 11 / GCP-compliant audit history.
      tags:
      - Audit
      parameters:
      - name: studyOID
        in: path
        required: true
        schema:
          type: string
      - name: SubjectKey
        in: query
        schema:
          type: string
      - name: SiteID
        in: query
        schema:
          type: string
      - name: StartDate
        in: query
        schema:
          type: string
          format: date-time
      - name: EndDate
        in: query
        schema:
          type: string
          format: date-time
      - name: PageSize
        in: query
        schema:
          type: integer
          default: 100
          maximum: 1000
      responses:
        '200':
          description: Audit records
          content:
            application/json:
              schema:
                $ref: '#/components/schemas/AuditRecordListResponse'
components:
  schemas:
    AuditRecordListResponse:
      type: object
      properties:
        records:
          type: array
          items:
            $ref: '#/components/schemas/AuditRecord'
        totalCount:
          type: integer
    AuditRecord:
      type: object
      properties:
        auditID:
          type: integer
        subjectKey:
          type: string
        siteID:
          type: string
        formOID:
          type: string
        fieldOID:
          type: string
        oldValue:
          type: string
        newValue:
          type: string
        auditType:
          type: string
        userID:
          type: string
        auditDateTime:
          type: string
          format: date-time
        reason:
          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/