As emphasized in Part 1 of this series, sponsors are responsible for the protection of human subjects and the quality and integrity of their data when it comes to the conduct of clinical investigations for investigational drugs and devices. From a high level, this responsibility presents as a daunting task for a commonly difficult problem to mitigate and diagnose. However, there is a way to break down key elements of oversight in a holistic way to ensure that sponsors are using the best approach with regard to scientific misconduct and fraud: robust site evaluation and selection, a comprehensive monitoring and risk management process, in-depth data reviews, and proactive reporting.
Robust Site Evaluation And Selection Criteria
This piece is a useful reference for US clinical trials sponsors. Many jurisdictions (including Australia) have similar expectations of sponsors in those countries. Some, but by no means all, research institutions serve both as trial sites and trial sponsors. Even if your institution is not a sponsor, these guidelines should inform your approach to the responsible conduct of trials at your site.
In addition to an operational evaluation, sponsors must perform their due diligence, whether taking on a new site or engaging a contract research organization (CRO). At minimum, sponsor review should involve a thorough check of publicly available data, including verification of the FDA Debarment List, site warning letters, site follow-up communications, and any outcomes of FDA inspections. While debarment checks, for example, may be performed by a CRO, sponsors should be made aware of any outcomes of checks [FDA Compliance Program (CP) 7348.810 Sponsors and CROs].
Sponsor companies are responsible for the protection of human subjects and the quality and integrity of their data when it comes to the conduct of clinical investigations. This responsibility sounds daunting, but this article shares how to break down key elements of CRO oversight in a holistic wa…