FDA WARNING_LETTER - ICON Clinical Research, Inc. - June 12, 2008

This Warning Letter from the FDA to ICON Clinical Research LTD (ICON) details regulatory violations identified during an investigation into ICON's role as the contract monitoring organization for two clinical studies, (b)(4) and (b)(4), of the investigational drug (b)(4). The inspection, part of the Bioresearch Monitoring Program, aimed to evaluate research conduct, protect human subjects, and ensure data validity for New Drug Applications.

ICON was contracted by (b)(4) to provide clinical study management services, including developing monitoring plans, conducting on-site and telephone monitoring visits, writing reports, notifying the sponsor of critical issues, and tracking visits and protocol violations. ICON also agreed to perform 100% source document verification (SDV) and ensure protocol and regulatory adherence.

The FDA's review of inspection reports and ICON's responses revealed failures to adhere to statutory requirements and FDA regulations governing clinical investigations, specifically 21 CFR 312.50 and 312.56(a).

Key violations include:

1. **Failure to ensure proper monitoring of clinical investigations:** * **Deficiencies in case histories:** Monitors failed to identify instances of study drug administration to multiple subjects at the same time by a single coordinator/nurse, lack of required physical examinations/assessments, unrecorded times for drug delivery to nursing units, improper storage conditions for study drug in subjects' homes, undocumented out-of-range