Audit by Federal Agency

Overview

This guidance provides the process to follow when a federal regulatory agency (e.g., NIH, DOD, FDA) notifies principal investigators (PI) that they are subject to an audit or inspection. The PI must immediately notify the Human Research Protection (HRP) division and applicable University departments to ensure availability of personnel and time to assist with preparations.

Definitions:

Audit: A systematic and independent examination of trial-related activities and documents to determine whether trial related activities were conducted in compliance with the protocol and other regulatory requirements.

Inspection: The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s facilities, or at other establishments deemed appropriate by the regulatory authority(ies).

For Cause Audit or Inspection: Audits or inspections initiated due to a complaint, non-compliance, concerns about the qualifications of investigators or quality of the data, etc.

FDA Form 483: A list of observations made by the FDA representative during an inspection.

Description:

The PI must immediately notify the HRP in writing at askirb@pitt.edu about a regulatory agency audit or inspection notification. The email should include:

Subject Line – Audit / Inspection, with designation of high importance
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 / inspection: routine or for cause.

The HRP will notify the research team if members from the Office of Research Protections need to be present for the pre-audit/inspection interview.

The PI must notify other relevant parties of the audit/inspection (i.e., department chair, study sponsor, study team members, contract research organization, investigational drug service, labs).

The PI and research team are encouraged to review the Regulatory Agency Audit/Inspection Checklist and the FDA Inspection Guidance documents found in the Education and Compliance Support for Human Subject Research (ECS-HSR) Good Clinical Practice (GCP) Toolbox.

If time permits, the PI may contact the ECS-HSR to request a consultation or review of study documentation.

The PI must notify the HRP through askirb@pitt.edu of the date of the exit interview so that arrangements can be made for the Institutional Official or their designee(s) to be present for the exit interview.

After the Audit/Inspection

The PI must send the written response to the report to the HRP (askirb@pitt.edu) for review and comment at least 5 business days BEFORE sending it to the agency.
For information on responding to an FDA Form 483, refer to the FDA Inspection guidance found in the ECS-HSR Good Clinical Practice (GCP) Toolbox. Responses to the FDA are due within 15 business days following receipt of an FDA Form 483.
The PI must promptly notify the HRP of any regulatory agency correspondence requesting that a clinical hold is placed on any human subject research.
If you failed to notify the HRP in advance of the inspection, the agency report and response to the report must be submitted to the IRB as Reportable New information (RNI).

Resources:

10/4/2024