The Post Approval Monitoring (PAM) and Education program has three goals:
- Enhance protection of research subjects
- Enhance quality of research data
- Enhancement of the education program
Post-approval monitoring is done by staff within the office of the Vice President for Research (VPR) in accordance with their Standard Operating Procedures.
The University of Virginia is committed to the protection of human subjects involved in research studies. In pursuit of this commitment and to satisfy federal regulatory agencies, a Human Research Subject Post Approval Monitoring and Education Program (PAM and ED) was initiated in 2002.
The purpose of this program is to assess the clinical research activities conducted under the University’s Federal Wide Assurance Agreement with the Office of Human Research Protections (OHRP). This program assures human subject safety in research, provides education to research professionals, and identifies strengths and areas for improvement in research practice at the University of Virginia.
The purpose of the program is to provide internal oversight on compliance issues relating to the performance of human research trials. The emphasis of the program is:
- To ensure the rights and well-being of research subjects and the quality and integrity of the research
- To identify educational and research support needs
- To ensure compliance with federal, state, local and institutional regulations and guidelines
- To identify areas of strength and needs of improvement in research policies and practice