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.
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. For example, using a binder will help organize study related documents.
- Make sure that each study team member has Human Subjects Researcg 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 the UNC Charlotte research community.
What study materials need to be prepared?
PAM includes a review of the IRB records compared 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
Dr. Angelica Martins 704-687-1876, Executive Director, Office of Research Protections and Integrity
Cat Runden 704-687-1871, IRB Manager, Office of Research Protections and Integrity