Post Approval Monitoring and Education Program (PAM / ED)
The UVA PAM / ED program is supported by the VPR, IRB-HSR, and SOM and was created to provide internal compliance oversight and identify educational needs related to the conduct of human subject research. Random post approval monitoring reviews are conducted on all active IRB-approved full-board or expedited clinical research studies. During a review, the monitor meets with the study team and then inspects study records to assess adherence to the approved protocol and Good Clinical Practice. Following the review, the compliance monitor prepares and shares a report with the study team offering a summary of the review and recommendations for improvement. Information learned from the reviews is also used to develop wider educational offerings, provide feedback to the IRB and improve institutional research policies and procedures. The membership of the PAM Working Group consists of the two post-approval monitors, the UVA School of Medicine Clinical Trials Office Educator and Director, the IRB Educators, IRB Director and Associate Director, and the Associate Vice President for Research. A voice-over "Learning Short" is also available describing the PAM program.