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University of Wisconsin–Madison

OVCRGE

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.

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).

4. What happens once a study is selected for a monitoring visit?

The study team will receive notification from a monitor that their study has been selected for monitoring. The monitor will confirm with the study team that their study meets selection criteria, and an initial visit will be scheduled. At this initial visit, the monitor will describe the monitoring process and discuss the study with the study team. The study team will also have the opportunity to ask questions ahead of the actual monitoring visit.

5. How should study teams prepare for the monitoring visit?

At the initial visit the monitor will provide the study team with a self-assessment tool. This self-assessment tool will closely mirror the evaluation tool used during the monitoring visit (Self-Assessment Tool). Study teams should ensure their study records and materials are present and organized, and that they have any preliminary questions answered prior to the monitoring visit.

6. What will happen during a monitoring visit?

The study team will have received a letter before this visit outlining what will occur. The monitor will arrive as scheduled and will spend time reviewing study records and materials. Study teams are encouraged to ask questions throughout the visit. At the end of the visit, the monitor will meet with study team members to briefly discuss the visit and ensure any study team questions are answered.

7. What results can study teams expect from the monitoring visit?

Study teams will receive a follow-up letter within 20 business days of the monitoring visit. This letter will provide study teams with an overview of the findings of the visit and any potential follow-up actions that may be needed.

8. What if a study already has research monitoring?

Post-approval monitoring selection letters ask whether there is existing monitoring and if so what this monitoring consists of. If the post-approval monitoring team determines that a study has robust monitoring, it will be exempt from routine review. The post-approval monitoring team will generally determine monitoring to be robust when: 1) it is conducted annually, 2) by an individual/individuals that are not part of the study team, and 3) addresses the same areas covered in the Post Approval Monitoring Self-Assessment Tool.

9. Are the post-approval monitors authorized to view my research records?

Section IV. of the Compliance Monitoring and Quality Improvement  policy describes the various research compliance mechanisms across campus which includes Office of Research Compliance staff.

10. Are there other ways the PAM Program can assist in improving the conduct of my research?

The PAM Program offers several service meant to assist researchers across campus. These services include in-person presentations, fall and spring drop-in Q&A sessions, and pre-enrollment consultations. More information on these services can be found here.


Keywords: post-approval monitoring, routine review, research compliance, research monitoring, self-assessment tool,