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

Site evaluation is the foundational element for ensuring a site is able to conduct studies compliantly. The site feasibility process provides the sponsor with a distinct overview of how sites can operate, considering the requirements of your study and protocol. A robust site feasibility process should minimally consider the number of active studies per principal investigator, study coordinator, research program coordinators, data coordinators, and other site staff. This may even include interviewing staff, including monitors and investigators, during site initiation visits (SIVs). Site staff interviews present an opportunity for sponsors to assess a site team’s overall understanding of fraud and misconduct and set sponsor expectations for compliant operations. Sponsor representatives may participate during these interviews, in which they can tailor interview questions that probe for how a monitor should handle suspected misconduct or identification of systemic data irregularities. Selected monitors should actively identify systemic data irregularities across patients at the given site. Furthermore, a thorough evaluation of study-specific equipment and facilities will help sponsors understand capabilities and organizational design of a site and whether a particular study is suitable for day-to-day study conduct.

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].