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) or ceded by UW-Madison to an external 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)/study team members 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 a conversation with the study team to discuss how the study is being conducted and a review of study records. 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.
Post-Approval Monitoring Process
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, such as an IRB or the study team.
How are studies selected for routine monitoring visits?
With a few exceptions, all non-exempt studies that have received approval from a UW–Madison IRB or have been ceded by UW-Madison to an external IRB may be randomly selected for a routine monitoring visit as long as they are open and active.
How often will routine monitoring occur?
Routine monitoring of a study typically occurs once.
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).
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.
How should study teams prepare for the monitoring visit?
Prior to the monitoring 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. Study teams should ensure their study records and materials (such as consent forms, eligibility documentation, record of study procedures) are present and organized, and that they have any preliminary questions answered prior to the monitoring visit.
What will happen during a monitoring visit?
The study team will have received communication 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. If study materials are maintained electronically, the monitoring visit may occur remotely. 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.
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.
FAQs
What if a study already has research monitoring?
Post-approval monitoring selection emails may 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) it is conducted by an individual/individuals that are not part of the study team, and 3) it addresses the same areas covered in the Post Approval Monitoring Self-Assessment Tool.
Are the post-approval monitors authorized to view my research records?
HRP-061 – SOP – Ongoing Evaluations of the HRPP describes the various research compliance mechanisms across campus which includes Office of Research Compliance staff.
Are there other ways the PAM Program can assist in improving the conduct of my research?
The PAM Program offers several services meant to assist researchers across campus. These services include in-person presentations, study team-requested reviews, and pre-enrollment consultations. More information on these services can be found in the PAM Program Services tab.
PAM Program Services
The Post Approval Monitoring (PAM) Program offers a number of free services to study teams to promote compliance with applicable policies and regulations. For more information about these services or to schedule a service, contact the PAM Program at hrpp@research.wisc.edu.
General Presentations:
A representative from the PAM Program can give a presentation to your program or department on various topics related to conduct of human participants research. Presentations can vary in length from 10-30 minutes depending on the topic(s) you would like presented. The presentation can include information on the following topics:
- What to expect from a routine monitoring review
- Tips for successful monitoring and avoiding common problems
- Common findings from PAM reviews
- General Q&A session
Post-IRB Approval Consultation:
Following IRB approval and prior to enrollment, study teams can request a consultation from the PAM program. At this meeting, the study team will discuss their plan for conducting the study with one of the post approval monitors. The monitor will provide the study team with study conduct feedback, recommendations, and documentation tools/templates that can make for more efficient conduct, improved documentation, and simpler compliance.
Study Team Requested Monitoring:
For active studies, a representative from the PAM Program can conduct post-approval monitoring to help identify and correct any outstanding issues and ensure the study is being conducted in compliance with the IRB approval and applicable policies and regulations.
Post-Approval Monitors
Peter Johnson peter.johnson3@wisc.edu
Peter comes to the Post Approval Monitoring Program with experience conducting clinical trials since 2007. Peter’s last position was at the UW–Madison Department of Surgery, where he worked on a thyroid cancer study as a Research Coordinator. He has also spent time at Swedish Hospital in Seattle, WA, where he worked on studies in pediatric endocrinology, pain, and HIV. Peter graduated from UW–Madison with a BS in Psychology.
Emily Putman-Buehler emily.putman@wisc.edu
Emily has been part of the Post-Approval Monitoring Program since 2017. Before joining the Post-Approval Monitoring team, Emily worked for the office of Research and Sponsored Programs, where she gained an understanding of the grant process and regulations surrounding research at UW-Madison. Emily holds a B.S. in Psychology from Indiana University and a M.A. in Clinical Mental Health Counseling from Ball State University.
Katie Schjei schjei@wisc.edu
Before working as a Post-Approval Monitor, Katie worked as a Clinical Research Coordinator in UW Orthopedics. She began working at UW-Madison in 2013 as a CRC in the Carbone Cancer Center and worked as a Regulatory Specialist there as well. Prior to that, Katie worked as a CRC at the Coordinating Center for a multi-site clinical trial in Pediatric Orthopedics (BrAIST) at the University of Iowa, where she also obtained her MA in Developmental Science. Additionally, Katie worked as Research Assistant in Neuropsychology at the Cleveland Clinic after receiving her BS from John Carroll University in Cleveland, Ohio.