This policy applies to all principal investigators who conduct clinical investigations that are regulated by the FDA and clinical investigations that support applications for research or marketing permits for products regulated by the FDA. The purpose of this policy is to outline the specific procedures that should be followed when principal investigators conducting human subject research that is subject to FDA regulations are notified of an FDA inspection.
Responsibilities of Principal Investigator
Principal investigators conducting human subject research that is subject to FDA regulations are responsible for promptly notifying the Institutional Review Board (IRB) about inspections being conducted by the FDA for the purpose of either surveillance3 or compliance4 .
Investigators must also notify the IRB immediately of any FDA correspondence requesting that a clinical hold be placed on any human subject research.
Notifications must be made in writing and sent to the Director of Regulatory Affairs. The notice should include reference to the IRB protocol number, the date and location of the planned inspection, any information available as to whether the inspection is for surveillance or compliance.
Investigators should facilitate arrangements to ensure that a member of the RCCO is present for the FDA exit interview.
Investigators must provide the IRB with copies of any written correspondence received from the FDA as a result of the inspection, in particular any Form 483.
Investigators must submit all written responses prepared as a result of the FDA Inspection to the IRB Committee F for review and comment PRIOR to sending the final response to the FDA. Such responses shall be forwarded to the IRB within 10 working days of receipt of the final FDA report.
Responsibilities of the RCCO Staff
The Director of Regulatory Affairs of the IRB Office shall notify appropriate parties of the upcoming inspection. This includes the IRB Chair, Co-Director of the Research Conduct and Compliance Office, University or UPMC Legal Counsel, the Authorized Institutional Official and the Education and Compliance Office for Human Subject Research. If applicable, O3IS will be notified as well.
On a case by case basis, the Education and Compliance Office will conduct a comprehensive review of the IRB file to ensure that the file is complete and in order. Any findings of non-compliance observed from this review will be reported to the Chair of the IRB, Director of Regulatory Affairs of the IRB and Co-Director of the RCCO, who will assess the findings and develop a plan of corrective actions as deemed appropriate.
The Education and Compliance Office shall contact the Principal Investigator and make arrangements (if time permits) to conduct a review of the research subject records and regulatory files in advance of the FDA inspection to ensure compliance with IRB policies, FDA regulations and Good Clinical Practices.
All requests for information surrounding the FDA inspection shall be treated as a priority by all involved parties.
The Authorized Institutional Official and/or his/her designee must be included in the exit interview.
Any Form 483 issued as a result of the inspection shall be reviewed by the IRB Committee F for determination of whether any observations contained therein constitute serious or continuing non-compliance with the federal regulations governing human subject research as outlined in Chapter 17 of this document.
In the event that an IRB Committee F meeting is not scheduled within 5 working days of receipt of the investigator’s response, a special meeting of the Committee may be convened for purposes of reviewing the response.
3 A surveillance audit is a routine FDA inspection, concentrating on basic FDA requirements (i.e., good clinical practice compliance).
4 A compliance inspection is based on a specific objective.