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