FDA EIR - Manoj K. Patel - May 03, 2011

This FDA For-Cause Inspection, conducted from April 4 to May 3, 2011, focused on Clinical Investigator Dr. Manoj K. Patel in Riverside, CA. The inspection served as an expansion of previous audits, validating clinical investigator data under the Bioresearch Monitoring Compliance Program (CP 7348.811).

Key issues reviewed included sponsor-reported findings from 2008, such as backdating by Dr. Patel and study staff, enrollment of study staff as subjects, and suspicious handwriting similarities on source documents. A prior FDA inspection in November 2010 had resulted in an FDA-483 for Dr. Patel, citing failures in conducting investigations according to the plan, administering study drugs without adequate personal supervision, and insufficient documentation of informed consent.

The current inspection specifically investigated protocol HCT 3012-X-302, confirming Dr. Patel's absence from the country and state during critical study periods in 2008. During one such absence, a study coordinator reportedly performed a medical examination on herself as a study subject and signed Dr. Patel's signature. While investigators collected case report forms and travel itineraries, they could not obtain affidavits from the site director or study coordinator due to outdated contact information. No new FDA-483 was issued during this particular inspection, but the findings validated previously identified serious concerns regarding supervision, data integrity, and adherence to investigational plans.