Welcome to UNC Charlotte's Post Approval Monitoring program website.
A Post-Approval Monitoring (PAM) program functions as the most significant quality assurance and improvement component of the Human Research Protection Program (HRPP). Through consistent auditing, education, and monitoring, it ensures regulatory compliance, improves investigator as well as Institutional Review Board (IRB) performance using measures that gauge the overall quality, effectiveness, and efficiency of the HRPP. The PAM program will move the UNC Charlotte HRPP towards accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
What should every investigator know?
- Studies are randomly chosen for PAM.
- If chosen for PAM, you will be required to participate by university policy.
- Keep all records in an organized manner. Using a binder will help organize study related documents.
- Make sure that each study team member has training that is up-to-date.
- Make no changes to your study or study documents without IRB approval.
- PAM results are reported to the VC of Research as the Institutional Official (IO) for the IRB.
- PAM results can lead to education for investigators, improve communication between the IRB and investigators, and a more efficient IRB process to best serve UNC Charlotte research community.
What study materials need to be prepared?
The PAM committee will compare the IRB records on file with those that the investigator stores for a study. To help investigators prepare for PAM, a checklist of common study documents will be provided prior to the PAM review period.
What actions may result from a PAM review?
- No issues found and no action required
- Recommendations or suggestions for consideration by the PI, such as sharing current best practices
- Additional education for the Investigator and/or study staff
- Items requiring action – study modifications, adverse events
- Endorse to IRB for consideration of non-compliance findings
When will the PAM program be launched?
A pilot program is scheduled to begin during the 2019 spring semester, and you will be contacted if your study is selected for review.
Angelica Martins 704-687-1876, Interim Director, Office of Research Compliance