Post Approval Monitoring (PAM) reviews are performed to provide assurance to regulatory agencies that projects are conducted in a manner that is consistent with the approved protocol. PAM reviews are performed for both human and animal related research.
Post approval monitoring (PAM) reviews are performed to provide assurance to regulatory agencies and the IACUC that animal experiments are performed in accordance with approved IACUC protocols. A PAM review will confirm consistency and accuracy of approved protocols and practice. It includes an examination of records, lab facilities and observation of procedures.
How are protocols chosen for review?
Selection of protocols includes a cross section of species, campuses and departments with an emphasis on:
- Pain category: All active protocols involving procedures with Pain Category E will be reviewed at least once a year.
- Survival Surgery: novel, high risk procedures will be reviewed.
- USDA regulated species.
- Labs with past compliance issues.
What can you expect during a PAM review?
- An appointment will be set up, in advance, between the Oversight & Outreach Specialist, the PI and/or other members of the research team. For Cause reviews may be conducted at any time, with or without prior notice to the PI.
- During the meeting, you will be asked about how the research project is going with regard to animal number, adverse events, etc. Records (training, drug, surgical, post-operative monitoring) will be reviewed for completeness.
- Whatever procedures are currently being done as part of the protocol will be observed to confirm that they are being done as described in the protocol.
- Whenever possible, the Oversight & Outreach Specialist will discuss the results of the review with the PI or research team before leaving the laboratory.
How long will the assessment take?
- If all records are available, the initial review will take approximately one hour. Procedural observations will last as long as the procedure and should be as unobtrusive as possible.
What happens after a PAM review?
- The Oversight & Outreach Specialist will write up a report using the Post Approval Protocol Review Sheet. The report will include a brief description of the observed procedures, any noted deficiencies, suggestions for improvement and any action items that must be addressed. A draft will be sent to the PI for comment.
- The final report will be sent to the PI, IACUC Chair, IACUC Director and Assistant Dean for Regulatory Affairs & Research Integrity. A brief summary will be verbally reported to the IACUC during its monthly meeting.
- The PI has 30 days to respond to any actions that must be taken and submission of any amendments required.
What are the possible outcomes of a PAM Review?
- If fully compliant, no follow up is needed.
- Minor deficiencies and resolutions are reviewed by the IACUC Chair and Vice Chair.
- Serious concerns or incidents of noncompliance are brought before the full IACUC for discussion and resolution.
Post Approval Protocol Review Sheet
SOP: Post Approval Protocol Monitoring (PAM)
Best Practices for Ensuring Quality Care of Research Animals and Maintaining Compliance
The purpose of the Oversight & Outreach (O&O) review is to ensure the safety, rights, and welfare of the research subjects and that subjects are not put at unnecessary risk. The monitoring review evaluates the study data separate and independent from external monitoring by entities including the federal government, study sponsor, and contract research organizations. During each monitoring review, the trial conduct, procedure, and processes will be evaluated.
Learn more about the monitoring and oversight (M&O) review and the selection process for human research studies.
Reason for Oversight & Outreach Review
Through monitoring, the O&O Specialist can assess the study staff’s knowledge and compliance with the OHRP and FDA regulations as well as GCP guidelines. The specialist will also assess any training needs of the study staff. Any deficiencies with the staff and/or study will be identified and a corrective plan will be designed.