Warning Letter Says Clerk Told to Perform Physical Exams

摘要

A man hired to enter data on case report forms in a clinical trial was told to conduct physical exams of patients, which he admitted he was not qualified to do, according to an FDA warning letter. The letter to clinical investigator Arturo Corces of the Miami Institute for Medical Research said a patient's physical exam was conducted while Corces was in England, and another patient's assessment for deep vein thrombosis/ postoperative pulmonary emboli was based on answers to questions instead of a clinical exam by a qualified individual.