Division of Research
Post Approval Monitoring (PAM) Program
What is Post Approval Monitoring (PAM)?
Post Approval Monitoring (PAM) is a systematic process of reviewing and assessing IRB-approved human subjects research studies after the initial approval has been granted.
The goal of the PAM program is not meant to be punitive. The process is meant to be collaborative and supportive for researchers. The overall program serves a few purposes:
- Protecting Participants: Ensuring that all research activities are conducted exactly as approved by the IRB and adhere to federal regulations (45 CFR 46) and institutional policies, thereby minimizing risk to participants.
- Supporting Researchers: Providing educational guidance, identifying potential compliance risks, and helping research teams correct deficiencies and implement best practices.
- Improving Research Quality: Ensures best practices resulting in a stronger assurance of quality research data.
Types of Monitoring Visits
| Type | Description | When It Occurs |
|---|---|---|
| Routine | A scheduled monitoring visit of randomly selected studies based on risk level, study complexity, or volume of research. | Pre-scheduled, studies selected randomly or based on risk stratification. |
| Directed | A requested monitoring visit initiated due to a specific concern, such as a report of serious non-compliance, recurring protocol deviations, or a high volume of adverse events. | Initiated immediately following a concern raised to the IRB or HRPP. |
| Proactive | A scheduled monitoring visit at the request of an Investigator who would like a compliance assessment of a study. | At the request of an investigator. |
| Check-Ins | A brief check-in of randomly selected exempt research. | Exempt studies selected randomly. |
Check-Ins
Check-Ins provide the Brown HRPP another avenue to ensure quality across the program by providing brief touch-points for exempt studies.
Randomly selected exempt studies will receive a comment on their study’s record in Huron IRB, requesting a brief (no more than 3-4 sentences) update on the study. This allows researchers to reflect on their progress and consider what they’re doing to stay compliant while keeping the HRPP informed.
How to Prepare for a PAM Visit
If your study has been selected for a PAM visit, the PAM coordinator will contact your Principal Investigator (PI) to schedule the audit and provide an initial document request list. Effective preparation will help ensure a smooth and successful visit.
1. Organize Your Regulatory File
Ensure your central regulatory file is complete, up-to-date, and readily accessible. This file should contain:
- IRB Communications: All approval letters, continuing review acknowledgments, amendment approvals, and correspondence.
- Approved Documents: The currently approved protocol, consent forms (signed and stamped versions), and recruitment materials.
- Investigator Credentials: Current CVs, licenses (if applicable), and documentation of required human subjects research training (e.g., CITI) for all study personnel.
- Delegation of Authority (DoA) Log: A record detailing all study staff and the specific tasks they are authorized to perform, with associated dates.
2. Prepare Participant Records
Ensure all participant-specific documents are complete and organized. The auditor will need to review a sample of records:
- Informed Consent Documentation: Signed and dated consent forms showing the participant received the currently approved version before any study procedures occurred.
- Eligibility Verification: Documentation showing that the participant met all inclusion and no exclusion criteria.
- Source Documents: All records (e.g., medical records, questionnaires, case report forms) that document study procedures, data collection, and adverse events.
3. Review Reporting History
Review your study’s history of reporting to the IRB:
- Confirm that all required events (e.g., unanticipated problems, serious adverse events, non-compliance, and deviations) were reported to the IRB within the required institutional and federal timelines.
4. Coordinate Study Team Availability
The PI and key study staff should be available during the visit to answer questions about the study conduct, consent process, and data management procedures.