Internal Compliance Reviews
The OCR conducts periodic compliance reviews of the responsibilities of the Sponsors and Principal Investigators’ of IND/IDEs and their protocols, conducted within the PSOM and approved by the Penn Institutional Review Board (IRB). These reviews ensure that clinical research in the PSOM is conducted in compliance with applicable regulations, guidelines, and internal policies and procedures.
The OCR Compliance Division works closely with the research faculty and staff throughout the compliance review process providing not only a review of the research compliance but also an educational opportunity for the research team. The OCR aims to, first and foremost, support research personnel in their management and conduct of clinical research, and recognizes the challenges of these roles. Our compliance reviews provide feedback and suggestions for informing and improving research processes. OCR is also interested in all suggestions for how to best facilitate compliant research conduct within PSOM.
Currently, the OCR focuses its efforts on the routine compliance review of the responsibilities of:
- University and Penn faculty who are IND or IDE Regulatory Sponsors, and
- Penn faculty who are Principal Investigator on a protocol conducted under a Penn faculty-held IND/IDE.
However, the OCR can conduct Compliance Reviews of any PSOM protocol as requested by the IRB. Also, Principal Investigators that are concerned about the compliance of their research may contact OCR to discuss the possibility of performing a compliance review.
The Principal Investigator or Sponsor and their main study coordinator are notified that the OCR will be conducting a Compliance Review of their protocol(s) and/or IND/IDE.
OCR Compliance Division works closely with the faculty and coordinator to schedule the most mutually convenient time and location for the Compliance Review.
Any findings or suggestions that result from the review will be communicated to the Investigator/Sponsor and the research team before a final Compliance Review report is issued.
Investigators are provided with a written report of their responsibilities, and the Sponsors are provided with their report plus a copy of the report of the protocol review. The OCR will work closely with the research team to provide any additional support or training necessary as a result of the audit findings.
FDA Inspection Preparation
Investigators who are notified that they, or one of their protocols, are the subject of an FDA inspection should notify the Office of Clinical Research. The Compliance Division of the OCR will work with the Investigator and his/her research team to conduct a pre-inspection review and assist the team in preparing for the inspection.
Contact the OCR
External Audit Preparation
There may be some circumstances in which an external agency or company requests to audit your research files. The OCR can assist in preparing for such an audit, and in responding to any findings that are identified during the audit.
Contact the OCR
There may be some circumstances in which an external agency or company requests to audit your research files. The OCR can assist in preparing for such an audit and in responding to any findings that are identified during the audit.
Contact the OCR
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