Assistance With Federal or Other Governmental Audits

RQA provides centralized support for Principal Investigators (PIs) and research teams before, during, and after audits or inspections by federal agencies (FDA, OHRP, NIH, EMA) and other governmental bodies.

🔗The University of Miami Policy: Hosting External Governmental Audits of Clinical Research (policystat.com) describes the process instituded to facilitate external audits.

Cards

NOTIFICATION REQUIREMENT

  • PI's and research teams must notify RQA immediately upon receiving an audit notification.

RQA RESPONSIBILITIES

  • Leadership Notification: Inform University leadership of the announced audit/inspection.
  • Audit Hosting:  Provide support and resources for external inspectors during on-site visits.
  • Preparation & Guidance: 
    • Advise PIs and study teams on audit preparation and interaction with inspectors.
    • Assess site readiness and summarize deficiencies if time permits
  • Logistics:
    • Provide a secure, dedicated room for the audit.
    • Accompany PIs and teams during initial meetings, interviews, and debriefings.
  • Issue Management: Update University officials on potential issues during or after the audit.
  • CAPA Support: Guide PIs and teams in developing Corrective and Preventive Action (CAPA) Plans.
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