FDAnews Drug Daily Bulletin

A clinical investigator in a study of Boehringer Ingelheim’s Spiriva inhaler failed to review the screening electrocardiograms (ECGs) for the majority of the 58 subjects the FDA audited, according to a warning letter. The FDA says it cannot tell how Daniel Paulson could have adequately determined that the subjects were eligible for inclusion in the trial “given that the ECGs were not documented as having been reviewed prior to the randomization visit.”
Clinical Trials Advisor