Post-Approval Monitoring Program
The Post-Approval Monitoring (PAM) Program was created to improve the quality, efficiency and effectiveness of the Human Research Protection Program (HRPP) by providing education and oversight for researchers conducting human subjects research approved by a UW-Madison Institutional Review Board (IRB).
The PAM Program functions to maximize the safety of research participants and ensure data integrity by confirming that research is implemented in a manner consistent with the IRB approved protocol and in compliance with applicable regulations and institutional policies. The PAM program also aims to provide researchers with education and tools to fulfill their role as principal investigators (PI) and reduce institutional risk.
Post-approval monitoring is a review of the conduct of IRB approved studies by a monitor internal to the university. Monitoring will typically consist of an in-person review of study records as well as data storage and security processes. Throughout the visit, monitors will be available for study team questions and comments about the review process. After the monitoring visit, the monitor will provide the study team with a report of any findings as well as recommended education and helpful tools to improve overall study compliance.
- Consent Documentation Tool and Instructions
- HRPP Education and Training Portal
- Preventing Noncompliance Guidance
- Developing an Internal Quality Assurance (QA) Program Guidance
- Investigating the Cause of Noncompliance and Implementing Corrective and Preventive Action (CAPA) Plans Guidance
Frequently asked questions:
1. What types of monitoring visits could occur?Routine: A routine visit occurs when a study has been randomly selected for monitoring. Most monitoring visits are of this type.
Directed: A directed visit occurs when the PAM Program receives a request for monitoring from an entity outside of the PAM Program.
2. How are studies selected for routine monitoring visits?All non-exempt studies that have received approval from a UW-Madison IRB may be randomly selected for a routine monitoring visit as long as they are open and active.
3. How often will routine monitoring occur?An individual PI may be selected for routine monitoring once every 12 months.
Example: PI Smith is PI on three studies (A,B,C). Study A has a routine monitoring visit occur. Now, neither studies A, B, or C can be selected for routine visits in the following 12 months (note: directed visits may still occur within 12 months).