🔔 Note: Stop playback at 23:08 to complete this lesson.
Presenter
Gabriel Davila, DVM
Biologist
Office of Study Integrity and Surveillance (OSIS)
Office of Translational Sciences (OTS)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
This presentation introduces the Collaboration Risk Evaluation and Surveillance Team (CREST), a vital component of the FDA’s Office of Study Integrity and Surveillance (OSIS) within CDER. CREST’s primary role involves conducting risk-based assessments of study sites to recommend them for inspection. The team evaluates a wide range of studies, predominantly in vivo bioequivalence (BE) studies, but also clinical endpoint, pharmacodynamic, in vitro BE, pharmacokinetic safety tolerability, and immunogenicity studies. CREST considers over 30 risk factors during its qualitative assessments, including a site’s inspection history, study complexity, unique aspects of conduct, and information from other regulatory bodies, while also verifying site information accuracy. The team assesses every pivotal study, every relevant site, and every submission, handling a significant workload, such as over 1200 submissions and 2300 sites in the previous calendar year. CREST faces challenges in managing a large international site inventory and providing timely, comprehensive assessments to meet user fee timelines.