Program Overview
The Yale HRPP Regulatory, Compliance, Quality, and Education (RCQE) Post Approval Monitoring (PAM) program supports Yale University, Yale New Haven Health System (YNHHS), and affiliated investigators in conducting human subjects research of the highest ethical standards and promoting confidence in the implementation of research activities.
PAM activities support the Yale HRPP’s mission to
- Ensure that the rights and welfare of human research participants are protected;
- Promote excellence in the conduct of research; and
- Advance scientific knowledge and quality research by facilitating adherence with federal regulations, state and local laws, and institutional policies and procedures.
The Yale HRPP RCQE team works in partnership with the Yale Center for Clinical Investigation (YCCI), Yale Cancer Center (YCC) Clinical Trials Office (CTO), and other Yale/YNHHS units to facilitate robust quality assurance (QA) activities, including PAM, of human subjects research, and ensures all Yale/YNHHS investigators, regardless of discipline, are supported in their research endeavors.
What is Post Approval Monitoring (PAM)?
Post-Approval Monitoring (PAM) is the process of reviewing research studies after they have received approval by the IRB to ensure that the study is being conducted ethically and in compliance with federal regulations, state and local laws, and institutional policies and procedures. Some benefits of PAM include:
- Enhancing the protection of research participants;
- Improving the quality of human research data; and
- Promoting an institutional culture of compliance
How are studies selected?
All active, non-exempt human subjects research studies are eligible for PAM. Studies are pseudo-randomly selected, with special emphasis placed on studies that involve greater than minimal risk to participants, vulnerable populations, emerging areas of research, and other complex study designs. Studies may also be selected for review if there are concerns about study conduct.
What happens once my study is selected?
The Yale HRPP RCQE team will notify the investigator that their study has been selected for PAM by email. The email will include details about the visit, including:
- Instructions for completing an Investigator Self-Assessment
- Specific areas to be reviewed
- Required attendees
- Suggested dates
- Request for access to study records
- Deadline for response
How should I prepare for the visit?
Preparation for a PAM visit should be minimal. We ask that the investigator or their designee complete an Investigator Self-Assessment and provide it to the Yale HRPP RCQE team and to make sure the requested study documents are available for review.
Investigator Self-Assessment
The Investigator Self-Assessment is intended to help investigators prepare for review and evaluate their own research programs. The self-assessment will help study teams and the Yale HRPP RCQE team prepare for the PAM visit by identifying areas that may need closer review as well as highlighting program and team strengths.
What happens during a PAM visit?
At the start of the PAM visit, the Yale HRPP RCQE team will meet with the investigator and designated study team members for a kick-off meeting to make introductions, set expectations, review PAM procedures, and answer any initial questions.
During the visit, the Yale HRPP RCQE team will review study records and may observe study activities to verify conduct aligns with the IRB-approved protocol and adheres to applicable regulations, laws, and institutional policies. The investigator or designated study team members should plan to be available throughout the visit to retrieve documents and provide clarification as needed.
A debriefing session will occur at the end of the visit (or at the end of each day of the visit, if applicable), to ensure the investigator and designated study team members are aware of findings and have an opportunity to make corrections in real-time. This is also an opportunity for the Yale HRPP RCQE team to review and clarify findings, answer questions, and provide guidance and education.
What results can I expect from the monitoring visit?
After the PAM visit, the Yale HRPP RCQE team will collaborate with the investigator and designated study team members to prepare a written report summarizing observations, offering recommendations for areas of improvement, and describing required corrections, if applicable.
A goal of PAM is to support investigators and their research teams in conducting human subjects research. The Yale HRPP RCQE team is available after the PAM visit to provide further assistance.