FDAnews Device Daily Bulletin

Reporting Failures, Use of Correction Fluid Draws Warning Letters

Nov. 7, 2007

Clinical investigators in two device trials have received warning letters for reporting failures, with adverse event reporting at one site delayed more than a month.

Baljit Sharma of Thoracic & Cardiovascular Surgery, Yakima, Wash., reported adverse events for 34 patients to the sponsor more than a month after they occurred, contrary to the study agreement, and failed to report documented adverse events on other patients’ case report forms (CRFs), according to a warning letter sent in 2006 and posted to the FDA website in October. Sharma also was cited for a number of documentation failures, such as using correction fluid to obliterate original data for two subjects and not having complete and accurate CRFs.

In another warning letter, Richard Kagan, chief of staff for burns at Cincinnati Shriners Hospital, was cited for failing to report and accurately document unanticipated adverse device effects and anticipated adverse events to the sponsor and the institutional review board.

Kagan and Sharma did not respond to requests for comment by press time. The warning letters can be viewed at www.fda.gov/foi/warning_letters/s6540c.htm (Kagan) and www.fda.gov/foi/warning_letters/s6539c.htm (Sharma).