CLINICAL INVESTIGATOR CITED FOR 'IDENTICAL' ECG RECORDINGS

Investigators studying a hypotension drug entered identical electrocardiogram (ECG) recordings for readings taken several weeks apart, while other staff reported that they had performed procedures on more than one subject at the exact same time, according to an FDA warning letter.

The warning letter to Olga Ostroumova, of the Department of Internal Medicine at Moscow City Hospital No. 23, said that the baseline ECG recording for a subject on June 21, 2004, and a recording for the subject's fourth visit on Aug. 2, 2004, "were identical except for the information hand-written on each ECG." The same was found for a second subject, whose baseline ECG recording taken on June 21, 2004, was identical to a recording for the fourth visit, on Aug. 3, 2004.

Separately, a subinvestigator reported doing baseline physical exams on two subjects at the same date and time, while another reported taking two subjects' blood pressure at the same date and time. A third recorded source notes for two separate subjects at the same date and time, according to the warning letter, which was sent Aug. 18 and posted to the FDA's website Oct. 5. There were also "two different source records" on a subject's chart and discrepancies in the records of how much of the drug was dispensed for the study.

The study was conducted for Shire Pharmaceuticals, which said it was "aware of the issues" and is working with the FDA to resolve them.

The warning letter can be accessed at www.fda.gov/cder/warn/2006/06-HFD-45-0801.pdf (http://www.fda.gov/cder/warn/2006/06-HFD-45-0801.pdf).