Post-Approval Monitoring (PAM) reviews may be conducted by the HRPP Regulatory Monitoring Analysts for routing or for-cause at the request of the IRB. PAM reviews are used to identify areas for improvement and suggest recommendations based on existing policies and procedures.
For routine reviews, HRPPO selects studies based on but not limited to the following criteria: high-risk studies, high-enrolling studies, Principal Investigators (PI) with a large volume of studies, PI-initiated studies, reported or potential non-compliance, and FDA-regulated trials.
Once the HRPPO determines which study will be monitored, the HRPPO staff will email the Principal Investigator, Research Coordinator, and Primary Administrative Contact with the IRB-approved protocol(s) that has/have been selected for review. A monitoring visit will be scheduled at a mutually convenient time.
The following will be the items that HRPPO may review during PAM visits:
- Regulatory documentation (protocols, adverse event documentation, IRB approval letters, etc.)
- CVs for the principal investigator and co-investigator(s)
- Signed and dated delegation log/signature Logs
- 1572, if applicable
- 1571, if applicable
- Monitor logs and monitoring documentation, if applicable
- Subject research records, including inclusion/exclusion confirmation documentation
- Drug accountability documentation, if applicable
- Signed informed consent documents
- Signed HIPAA authorization documents
- Enrollment logs
For additional questions about PAM visits please contact the HRPP office at 214-648-3060 or by HRPP@utsouthwestern.edu.