483
Dr. Norman R. WaselDr. Norman R. Wasel – FDA 483, Apr 11, 2014
Record Details
An FDA inspection of Dr. Norman R. Wasel, a clinical investigator in Edmonton, Alberta, revealed significant deficiencies in clinical study conduct. Observations included a failure to maintain adequate case histories with proper verification of electronic source data and a failure to obtain informed consent from human subjects in accordance with regulations, specifically regarding a revised consent document for study CC-1004-PSOR-009.
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