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Post-Approval Monitoring: What does a program look like?

Learn about the key components of a Post-Approval Monitoring program, including formalized reviews, personnel training, and assessment of effectiveness to ensure compliance.

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Post-Approval Monitoring: What does a program look like?

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  1. Post-Approval Monitoring: What does a program look like? Elaine N Joseph, PhD Regulatory Compliance Manager University of Michigan

  2. Today’s Outline • Why should we (and our PIs) care? • The many faces of “PAM” • How to make PAM more Efficient • Assessment of Effectiveness • Conclusions

  3. What is a PAM Program Anyway? • Formalized review of protocols by regulatory compliance staff • Detailed annual review of all protocols • Observation of surgical procedures by veterinary or compliance staff • Regular review of adverse events and unexpected outcomes • Inspections of laboratory spaces, surgical records, etc.

  4. Basic Structure UM PAM • Every investigator, every protocol, every year • Review of approved protocol(s) • Review of new/changed policies/guidelines • Review of personnel training reports • Review of records (e.g., surgical)

  5. Format of a PAM • Open-ended questions “Tell me about the surgeries you perform on this protocol.” “What kind of anesthetics do you use?” • Probing questions “How, exactly, do you prepare the animal for surgery?” • Open and non-confrontational atmosphere

  6. How to Make PAM do More with Less • Educate PIs • New and revised policies/guidelines • How to navigate online protocol system • Inspect Controlled Drug Storage/Use Logs • Inspect laboratory euthanasia stations/rodent surgery stations • Assess procedural competency by observing surgical/technical procedures

  7. How to Make PAM do More with Less • Gather/verify data for annual (e.g., USDA) census • Check laboratory training logs/data • Cross-verify compliance with IBC/Biosafety • Conduct the Annual Review (for USDA protocols)

  8. How do we Know PAM is Effective? • Increase number of protocol amendments • Decrease in number of serious/continuing non-compliance • Foster a cooperative and collegial relationship between the IACUC and investigators!

  9. Any Questions?

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