FDA 483 - McDougle, Christopher J., MD - March 12, 2004

The FDA issued a Form 483 to Dr. Christopher J. McDougle, a Clinical Investigator, following an inspection conducted from March 9 to March 12, 2004. The primary observation documented was a failure to prepare or maintain accurate case histories with respect to observations and data pertinent to the investigation. Specifically, the inspection identified numerous data entry errors when transferring study data into the database. Examples included discrepancies in adverse event resolution dates for subjects experiencing issues like "head movement" and "coughing/nasal congestion." Furthermore, significant errors were found in other study-related records for multiple subjects, with one record containing approximately 23 errors and others showing inconsistencies in question responses between source documents and the database. These findings underscore a critical lapse in data integrity, essential for the reliability of clinical trial outcomes. While the FDA 483 outlines observations, it implicitly necessitates that Dr. McDougle's firm implement robust corrective actions to ensure comprehensive and accurate record-keeping, thereby meeting regulatory standards for clinical research conduct.