Post-Approval Monitoring

Research Compliance & Education Program (RCEP)

The purpose of the PAM program is to monitor research projects campus-wide to confirm that the research is being conducted as approved by DU’s Institutional Review Board (IRB), thus ensuring compliance with the federal regulations and guidelines that govern research.  

 

Compliance Monitoring Goals

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    To confirm, by observation of study procedures and through direct communication with PI, the accurate and consistent protocol performance in a collegial and unobtrusive manner.  

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    To ensure the well-being of human subjects in research.  

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    To provide education to the investigators on best practices for conducting their human subject research study in compliance with their IRB-approved protocol, University of Denver IRB policies and guidance, and Federal regulations. 

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    To help investigators, their teams, and the University prepare for external audits by granting, regulatory, and accreditation agencies. 

Will My Study Be Subject to Post-Approval Monitoring?

  • Any human-subjects research protocol at DU is eligible for the Post- Approval Monitoring (PAM) program. Exempt, Expedited, and Full- Board studies will be included in the protocol randomization process. For more information, see “Protocol Selection.” 

  • For-Cause Audits are rare, but are conducted when there are concerns about whether or not the rights and welfare of participants enrolled in a particular research protocol are being adequately protected. 

 

If You're Selected for the PAM Program:

The Research Compliance Monitor will contact you to let you know that your protocol was selected and to guide you through the next steps. For a general overview of the process, please see Monitoring Process.