Post-Approval Monitoring

Research Compliance & Education Program (RCEP)

The purpose of the PAM油program is to monitor research projects campus-wide to confirm that the research is being conducted as approved油by 91心頭s Institutional Review Board (IRB),油thus ensuring compliance with the federal regulations and guidelines that govern research.油油

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Compliance Monitoring Goals

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

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

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    To油provide education to the investigators on best practices for conducting their human subject research study in compliance with their IRB-approved protocol, 91心頭 IRB policies and guidance, and Federal regulations.油

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

Will My Study Be Subject to Post-Approval Monitoring?

  • Any human-subjects research protocol at 91心頭 is eligible for the Post- Approval Monitoring (PAM) program.油Exempt, Expedited, and Full- Board studies will be included in the protocol randomization process. For more information, see Protocol油Selection.油

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

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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油Process.