FDA EIR - Worldwide Clinical Trials, Inc. - September 08, 2022

An FDA inspection of Worldwide Clinical Trials, Inc., a Contract Research Organization (CRO) located in Research Triangle Park, NC, was conducted from August 29 to September 8, 2022. This initial inspection, assigned by the Good Clinical Practice Assessment Branch, evaluated the firm's operations related to a clinical study involving an investigational FDA-regulated drug under Emergency Use Authorization. The inspection followed Compliance Program Guidance Manual CPGM 7348.810 for Bioresearch Monitoring-Sponsors and CROs, focusing on the company's oversight of 56 clinical investigator sites, with detailed review of four specific sites.

The scope covered various aspects including project management, regulatory services, adverse event reconciliation, clinical monitoring, and data collection. The FDA investigator thoroughly reviewed study master files, standard operating procedures, site monitoring procedures, and financial disclosures. A key finding of the inspection was that **no significant objectionable conditions or practices were observed, and consequently, an FDA Form 483 was not issued.** Minor issues, such as a data entry backlog at two sites (Site 017 due to EMR access and Site 054 due to staffing), were identified but were actively being addressed by the company and the sponsor. No specific required actions were mandated, though management was reminded of their ongoing responsibility to remain in compliance with applicable regulations. The inspection and collected exhibits will be forwarded to CDER for final classification.