Post-Approval 监控

Research Compliance & 教育 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 审查 Board (IRB), thus ensuring compliance with the federal regulations 和 guidelines that govern research.  

 

Compliance 监控 Goals

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    确认, by observation of study procedures 和 through direct communication with PI, the accurate 和 consistent protocol performance in a collegial 和 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 和 guidance, 和 Federal regulations. 

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    To help investigators, 他们的团队, 和 the University prepare for external audits by granting, 监管, 和 accreditation agencies. 

Will My Study Be Subject to Post-Approval 监控?

  • Any human-subjects research protocol at DU is eligible for the Post- Approval 监控 (PAM) program. Exempt, Expedited, 和 Full- Board studies will be included in the protocol r和omization 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 和 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 和 to guide you through the next steps. For a general overview of the process, please see 监控 Process.