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Clinical Misconduct: Examples and Implication for your Clinical Staff

The Buck Stops with the PI... or Does It? Regulation states that ultimate responsibility for a clinical trial rests with the principal investigator. This session will provide information on the implications and consequences of investigator and staff misconduct in clinical research. Using case studies and actual findings, participants will learn about clinical trials compliance, what kinds of misconduct have occurred in the past and the consequences of a finding of misconduct. Reasons for committing fraud will be explored.

Speakers:

  • Janet Holwell, CCRC, CCRA, FACRP, TIACR, Clinical Research Consultant, Independent Consultant

  • Dr. Michael Hamrell, RAC, CCRA, RQAP-GCP, PhD, President, MORIAH Consultants