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Audit by Federal Agency

Overview of Audit by Federal Agency

This guidance provides the process which must be followed when principal investigators (PI) are notified by federal regulatory agencies (e.g., FDA, NIH, DOD) that an inspection or an audit is being scheduled. It is important to notify University departments as soon as possible to ensure availability of personnel and time to assist with a comprehensive review if needed.

Definitions:

Random audit: As part of a general research oversight program, auditors will randomly choose studies to ensure they are being conducted properly.  It is not uncommon for sponsors, federal agencies, and compliance monitors to routinely select, by chance, studies to audit or possibly by populations studied.

For Cause audit: The audit may be initiated due to a complaint, non-compliance issue, concerns about the qualifications of investigators or possibly a high profile study. 
 
Form 483: A list of observations made by the FDA representative during an inspection.

Description:

To begin, principal investigators (PI) must notify the IRB in writing at askirb@pitt.edu about inspections/audits being conducted by a regulatory agency, as soon as possible. This should include:

  • IRB protocol number
     
  • date and location of the planned inspection
     
  • name of the agency
     
  • if known, the name of the inspectors or auditors
     
  • type of audit: random or for cause

Then do the following:

  1. The PI should make arrangements to ensure that the Authorized Institutional Official (or his designee) be included in the exit interview. The Authorized Institutional Official for the University of Pittsburgh is Bill Yates, PhD, Vice Chancellor for Research Protections.
     
  2. If time permits, the Education and Compliance Support (ECS) will make arrangements to conduct a comprehensive review of the IRB file, research participant records and regulatory files in advance of the inspection to ensure compliance with IRB policies, applicable federal regulations and Good Clinical Practices.
     
  3. Any report issued as a result of a regulatory inspection/audit (e.g., Form 483) must be submitted to the IRB for formal review to determine whether any observations contained therein constitute serious or continuing non-compliance with the federal regulations governing human subject research.
     
  4. PI must provide prompt notice to the IRB of any FDA correspondence requesting that a clinical hold be placed on any human subject research.
     
  5. Within 10 working days of receipt of the final agency report, the PI must submit any written responses that he or she has prepared to the IRB for its review and comment BEFORE sending that final response to the agency. The draft correspondence can be sent to askirb@pitt.edu.

Resources:

Food and Drug Administration (FDA)

1/21/2021