For Cause Investigation of Potential Fraud and Misconduct at Clinical Research Sites
For Cause Investigation of Potential Fraud and Misconduct at Clinical Research Sites
4 PagesFor Cause Investigation of Potential Fraud and Misconduct at Clinical Research Sites Background Owners of a research company suspected fraudulent activity on the part of senior management and investigators at 1 or more sites within its organization. As a result of their suspicion, Advarra ® Consulting was contacted to conduct a for cause investigation of potential misconduct and/or fraud. Methods Advarra Consulting developed a for cause investigation plan focused on adherence to International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines and US federal regulations (particularly 21 CFR Parts 11, 50, 54, and 312), data integrity, and verification of the subjects stated to be enrolled in the clinical studies. As the FDA does not define research misconduc
