Assistance With Federal Audits

RCQA provides assistance and support to Principal Investigators and research teams prior to, during and after an audit or inspection conducted by a federal agency such as FDA, OHRP, NIH, EMA, or any other governmental agency at the federal, state and local levels.

The University of Miami’s policy HSR-P-002: External Audits for Research was instituted to help facilitate external audits by providing RCQA as a centralized resource to support research teams throughout these external audits.  

As described in the policy HSR-P-002: External Audits for Research, Principal Investigators and research teams must notify RCQA immediately upon receiving notification of an upcoming audit by any external governmental agency.

Preparation For a Federal or other Governmental Audit

Once a Principal Investigator (PI) and RCQA have received confirmation of such audits, RCQA:

  • Notifies university leadership of the upcoming external audit
  • Meets with the PI and study team to coach them on how to prepare for the audit and how to interact with the external inspectors
  • Conducts an assessment of the research site’s preparation and readiness for an external audit. This assessment consists of a general review of the study records prior to the external audit, followed by a debriefing with the PI and study team to discuss any deficiencies identified
  • Provides a brief summary report to the study PI in order to offer guidance in their preparation for the external audit
  • Offers the use of a secure and dedicated room to host the external audit
Assistance During a Federal or other Governmental Audit

Representatives from RCQA accompany the PI and research team at the initial meeting with the external inspectors, and throughout the external audit, RCQA works closely with the PI and study team to facilitate and expedite the process of responding to questions or requests from the external auditors.

RCQA's role during and exteranl audit is to ensure that appropratie university officials are aware of onsite inspectors and potential issues that may arise during or as a result of an audit.

RCQA is present at all interviews of the PI or study team as well as at all debriefings, including the final exit meeting.

Assistance Following a Federal or other Governmental Audit  

RCQA provides guidance and support to the PI and study team in the development of corrective and preventive actions (CAPA) in response to an external audit. Please see RCQA’s CAPA services.