Post-Approval Monitoring

Research Compliance & Education Program (RCEP)

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

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Compliance Monitoring Goals

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

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

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

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

Will My Study Be Subject to Post-Approval Monitoring?

  • Any human-subjects research protocol at 快活app is eligible for the Post- Approval Monitoring (PAM) program.听Exempt, Expedited, and Full- Board studies will be included in the protocol randomization process. For more information, see 鈥淧rotocol听Selection.鈥澨

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

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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听Process.