FDA EIR - Valerie K Arnold MD - December 08, 2004

The FDA conducted a clinical trial inspection of Valerie Arnold, MD, a research site in Memphis, TN, from November 29 to December 8, 2004. The inspection, part of a Bioresearch Monitoring (BIMO) program, focused on a Phase III study (SLI381-314) of ADDERALL XR for adolescent Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Shire Pharmaceutical Development Inc. The inspection resulted in an FDA Form 483, highlighting deficiencies in recordkeeping practices that violate 21 CFR 312.62(b), which mandates adequate and accurate case histories. Key issues included inconsistencies where crucial changes in source medical files, specifically regarding "Clinical Global Impressions - Improvement" assessments, were not accurately transferred to the site’s copies of the case report forms for three patients. Additionally, one patient's diagnostic interview booklet was incomplete, failing to document all screened disorders. A further observation noted an improper correction on a case report form, where a blood pressure reading was crossed out without the correct value being subsequently recorded. These findings point to inadequate adherence to Good Clinical Practice standards for maintaining comprehensive and reliable study documentation. In response to the inspectional observations, the firm's management indicated their intent to submit a written response to the FDA.