More 483 violations for international clinical investigators in 2004 highlight need for training and added scrutiny.(Clinical investigators)

WASHINGTON -- More domestic companies are using international clinical investigators outside of Canada and Europe, which led to increased violations in protocol, records, informed consent and adverse event., in 2004 as compared to 2003 (See chart 1 on page 5), mostly due to the fact that these investigators are unfamiliar with FDA inspections. This means sponsors need to "screen potential offshore investigators carefully," said Donald Ashbrook, CEO, GPA International. "Check their capabilities, team track record and review their references."

The reason more sponsors are going offshore, he said at the Drug Information Assn. (DIA) meeting here recently, is no longer because of lower costs or reduced regulations, but because a …