Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight.

Roberts, Michelle K; Fisher, Dylan M; Parker, Lea E; Darnell, Doyanne; Sugarman, Jeremy; Carrithers, Judith; Weinfurt, Kevin; Jurkovich, Gregory; Zatzick, Douglas

The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants' enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance.