Post Approval Monitoring (PAM) or compliance monitoring is a program that monitors research projects to confirm that the research is being conducted as approved, thus ensuring compliance with the federal regulations and guidelines that govern research. The goal of compliance monitoring is to confirm, by observation, and direct communication with PI the accurate and consistent protocol performance in a collegial and unobtrusive manner. Another goal of the PAM program is to ensure the well-being of human subjects in research.
PAM visits and reviews are conducted by the IRB Quality and Compliance Advisor (IRB QCA) and team, a group within the Human Research Protection Office (HRPO). The IRB QCA’s role is to ensure that there is no bias in the reviewing and monitoring research activity that is being performed in accordance with approved Institutional Review Board (IRB) protocols and institutional Standard Operating Procedures (SOPs) as well research administration and research regulatory compliance practices and to provide leadership when conducting comprehensive reviews.
When conducting a PAM review the IRB QCA will speak to the PI and may observe the research activity and determine if it is being performed in accordance with the approved IRB protocol and institutional Standard Operating Procedures (SOPs). The IRB QCA or team member will document the findings of the PAM visit and provide a memo documenting the visit to the PI and IRB, as necessary.
Additionally, based on the information received from the PI and/or study team members, the IRB QCA can assist the HRPP in identifying areas of weakness in the program or the approval process and suggest improvements.
PAM is not designed to “catch” individuals; rather, it is designed to verify that research is being conducted as approved. If noncompliance is detected, it may be a result of lack of understanding of the roles and responsibilities of individuals involved in research and/or inadequate training of staff. Monitoring will allow the IRB and HRPO to respond to any identified trends.
The goal of post-approval monitoring of studies involving human subject research is to confirm by observation and documentation comparison, an accurate and consistent protocol performance, conducted in accordance with an Institutional Review Board (IRB)-approved protocol. An additional goal of the program is to provide education to the investigators on best practices for conducting their human subject research study in compliance with their IRB-approved protocol, Tulane University (TU) IRB policies and guidance, and federal regulations. The program is also designed to help investigators, their teams, and the University prepare for external audits by granting, regulatory, and accreditation agencies.
Perhaps the most effective way to prepare for a PAM visit is to carefully and objectively read your approved protocol and make sure that you and your staff are performing the research activities as described and approved by the IRB. Many variables can play into the need for adjustment in the design, procedures, etc., of your protocol. The main thing to remember is any changes to the IRB-approved protocol must be approved by the IRB prior to implementation. It is easy to be caught up in the progress of research and forget to submit an amendment. Likewise, an issue may seem trivial to a researcher, but it may be of great concern to the IRB, federal regulators, or auditors.
The staff of the HRPO is always willing to assist in answering questions or to help facilitate modifications to your protocol. They can be reached at 504-508-4392 or firstname.lastname@example.org if you have any questions prior to submitting your amendment.
Below are examples of common findings from post-approval monitoring visits:
If you have identified discrepancies between your current practices and those outlined in the approved protocol, please make the appropriate corrections. This may require submitting an amendment to your protocol or simply implementing better documentation practices.
Remember, the goal of post approval monitoring is not to “catch” you doing something you aren’t supposed to be doing. Rather, it is designed to facilitate research by making sure it is conducted in a manner where the conditions of federal regulations and University policy are met and by assisting researchers to identify and correct any deficiencies.
Human Subjects Research:
Additional FDA regulations:
Tulane University HRPO
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New Orleans, LA 70112