Post-Approval Monitoring

  1. Office for the Protection of Research Subjects (OPRS)
  2. Forms, Guidance, Resources
  3. Post-Approval Monitoring
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OPRS and IRB responsibilities do not end when an application is reviewed and approved. OPRS and the IRB provide ongoing oversight for all projects until they have been officially closed with a Final Project Report.

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About Post Approval Monitoring

Post Approval Monitoring is the program OPRS/IRB uses to confirm that the research is being conducted as approved, ensuring compliance with the federal and institutional regulations, policies, and guidelines for the protection of research subjects. 

The PAM program has three goals:

  1. Enhancing the protection of human research participants
  2. Improving the quality of human research data
  3. Serving as a training/educational opportunity for research teams as they conduct research

All studies, even those determined to qualify for exempt status, are subject to PAM. Receiving notification that a study has been selected for PAM does not imply that wrongdoing has occurred or is suspected in the conduct of the study.

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The Monitoring Process:

Random Selection

Studies are selected randomly, for cause, or as a result of a request by a PI, research staff, or department leadership.

Monitoring Methods

OPRS determines one of two monitoring methods:

  • Self-Assessment – PI and research team conduct an audit of their own project using tools OPRS provides and OPRS will review the results and determine if any additional actions are needed
  • Monitoring Site Visit – OPRS staff visit the location(s) where records are kept and research activities occur. 

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What To Expect on a Monitoring Site Visit

  • All research records are reviewed and procedures on the selected protocol(s) may be observed.
  • OPRS staff will meet with the PI and designated research team members to discuss any general conclusions at the end of the visit.
  • The PI will be provided with a written report of all findings including suggestions for corrective and preventive actions. 
  • The PI will have the opportunity to make any corrections and respond to the report. 

Tools for Monitoring Visits

OPRS has provided the worksheets and tools used to conduct monitoring visits. Researchers are encouraged to use these worksheets to conduct their own monitoring throughout the study or to prepare for a monitoring site visit. 

Behavioral Sciences Self-Assessment Worksheet

Biomedical and Health Sciences Self-Assessment Worksheet

Audit Worksheets

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