Post-Approval Monitoring (PAM) is a program that monitors human research projects to confirm that the research is being conducted as approved, thus ensuring ethical human research conduct and compliance with state and federal regulations, federal guidance, institutional policies, and best practices.
The goal of the PAM program is to improve investigator compliance with currently approved protocols/amendments, applicable regulations, and best practices (e.g., Good Clinical Practice (GCP)). Another goal of the PAM program is to ensure that the rights and well-being of human subjects are protected.
PAM routine visits and directed/for-cause reviews are conducted by HRPP staff members within the Office of the Vice President for Research. When conducting a PAM review the HRPP staff member will meet with PI and review research records to determine if the research is being conducted in accordance with the approved IRB protocol and applicable regulations and Standard Operating Procedures (SOPs). The findings of the PAM visit will be documented and generated into a report that is shared with the PI. The PI will provide a written response and corrective and preventable action (CAPA) plan, as necessary.
Information gathered from PAM visits can be used to identify areas of weakness or trends in the HRPP program and can be used to inform additional training programs or improved processes.