"Remember the basics!" is one message that Joel Picus of Washington University of St. Louis will likely carry away from FDA Warning Letter 10-HFD-45-09-02. In the letter, dated last month but referring to an October 2009 FDA visit, he is cited for poorly maintained records of the drugs used in the trial.
The letter says that certain drug accountability records contain discrepancies in dates, lot numbers and drug identification numbers--housekeeping matters that automation tools should be able to handle. Records don't account for some of the drugs received, while other drugs are recorded twice. Subject-specific drug accounting was also found lacking.
In a response to the FDA, Picus acknowledges the shortcomings and describes the corrective action he's taken, earning a nod from the regulator "if implemented as proposed."
Picus also is cited in the letter for supervisory shortcomings, failure to ensure that the investigation followed plan and an informed-consent violation. He proposes fixes in the November response, which the FDA acknowledges in the warning letter. The regulator accepts Picus' proposed corrections for sticking to the investigational plan, but expresses concern that they may not prevent future deviations from plan. And it labels "inadequate" Picus' response to the informed-consent violations because of lack of a proposed remedy.
- see the warning letter