Attorneys Examine Compliance Challenges for Clinical Research Sites in Food & Drug Law Institute’s Update Magazine

A Food & Drug Law Institute Update Magazine article examines compliance challenges for clinical research sites and investigators, and recent trends in U.S. Food and Drug Administration (FDA) enforcement of good clinical practice and human subject protection regulatory obligations.

The authors explain that clinical research regulations are designed both to ensure subject safety and the collection of high-quality data that can be used to inform product development and approval decisions.

Noting that compliance can be especially daunting for community-based health practitioners and clinics that are new to clinical research, the authors emphasize the importance of developing appropriate training and clinical research procedures, hiring qualified staff to whom tasks can be delegated, and having an experienced staff member conduct regular audits to identify areas for improvement. It is equally important that investigators familiarize themselves with the research protocol’s requirements and implement the protocol, as written, with minimal deviations.

The article was authored by health care partner David Peloquin, life sciences regulatory & compliance counsel Beth Weinman and life sciences regulatory & compliance associate Jessica DeLalio.