Inspection Readiness For Decentralized Trials: Lessons From FDA Inspection Of Pivotal DCT Study

Decentralized Clinical Trials (DCTs) enhance research inclusivity by minimizing logistical barriers such as travel, scheduling conflicts, and costs, making participation more accessible. This study provides a high-level overview of a DCT-based approach, explaining the rationale for its selection and the distinct responsibilities of the central Principal Investigator (PI) versus local investigators.

A critical aspect of conducting DCTs is ensuring regulatory compliance and preparedness for FDA inspections. This discussion incorporates the Bioresearch Monitoring (BIMO) checklist, guidance on PI interview preparation, and essential documentation requirements. The inspection process is closely examined in this presentation, covering the first-day agenda, PI interview topics, oversight responsibilities, source document management, Investigator Site File (ISF) review, and close-out procedures. Key learning objectives include developing FDA inspection readiness, implementing best practices for DCT facilitation, and strengthening PI oversight to maintain compliance and data integrity in decentralized research settings.