Post-Approval Monitoring

Research Compliance & Education Program (RCEP)

The purpose of the PAMprogram is to monitor research projects campus-wide to confirm that the research is being conducted as approvedby 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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    Toconfirm, by observation of study procedures and through direct communication with PI, the accurateand consistent protocol performance in a collegial and unobtrusive manner.

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    Toensure the well-being of human subjects in research.

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

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    Tohelp 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 “ProtocolSelection.”

  • For-CauseAuditsare rare, but are conducted when there are concerns aboutwhetherornottherightsandwelfareofparticipantsenrolledina particular research protocol are being adequatelyprotected.

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 MonitoringProcess.