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Risk-Based Monitoring: Multiple NIH-funded Protocols & Sites - NOT RECORDED

May 2, 2011 2:05pm ‐ May 2, 2011 2:05pm

Credits: None available.


The Division of AIDS (DAIDS) at the National Institute of Allergy and Infectious Diseases, National Institutes of Health is responsible for monitoring 80-100 protocols at 200+ clinical research sites (CRSs). DAIDS initiated process improvements to standardize and centralize clinical research oversight. Challenges faced include: varied approaches to monitoring plans across DAIDS Programs; decentralized oversight of CRSs and limited fiscal resources for the monitoring contract DAIDS collaborated with Dr. Gregg Claycamp, FDA expert on risk-based methodology to develop a protocol-risk ranking system. This system categorizes, scores, and assigns a protocol "Risk Level" and is used to standardize monitoring and allocate limited resources. DAIDS is developing an evaluation plan of process improvements.

  • List at least three attributes of clinical protocols which may impact risk to: human subject safety or data integrity
  • Identify at least two parameters to include in a risk-based monitoring plan
  • Identify at least two factors used to evaluate and adjust the frequency and nature of monitoring at clinical research sites



Credits: None available.

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