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Factors that influence the development and execution of risk based monitoring plans

Wednesday, October 10, 2012 — Poster Session II

Noon – 2:00 p.m

Natcher Conference Center, Building 45




  • A. Adams
  • B. Baseler
  • L. Giebeig
  • J. Pierson
  • S. Simpson
  • S. Vogel


To provide an overview of the development and execution of the Regulatory Compliance and Human Subjects Protection Branch/Program (RCHSPB/P) risk based monitoring (RBM) plans. These RBM plans align with ICH-GCP and the new Draft FDA RBM guidance. When developing RBM plans, RCHSPB/P focuses on the level of risk to the subject, as defined in Title 45 CFR Part 46, complexity of the study, critical study parameters and other various factors such as Quality Control/Quality Assurance plans. An analysis of observations of NIAID intramurally funded clinical trials has shown higher deficiencies in areas such as informed consent process, eligibility and safety reporting. The FDA has also noted these areas (human subject protection concerns) as deficient during their audits as evident in their warning letters. Included is a table comparing RBM plans utilized for different types of studies with different risk levels. Using the information from the analysis, RCHSPB/P focuses on these key items in the development and execution of the risk based monitoring plans as the example shows. Funded by NCI Contract No. HHSN261200800001E. This research was supported [in part] by the National Institute of Allergy and Infectious Disease. Clinical Research Directorate/CMRP, SAIC-Frederick, Inc., NCI-Frederick, Frederick, MD 21702

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