Clinical Investigator Warned for Telling Data Entry Clerk to Do Physical Exams

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.

Corces also was cited for giving English-language consent forms to Spanish speakers, a recurring problem in clinical trials. For example, one of Corces’ patients was given a 12-page form “with the first eight pages written in the English language and the last four pages written in the Spanish language. There was no documentation that this subject is bilingual in both English and Spanish,” the warning letter said. It was sent May 28 and posted recently to the FDA website.

The warning letter was based on an inspection conducted March 20 to April 26, 2007, and concerned Corces’ conduct of two studies. One trial was for a drug to prevent venous thromboembolic events (VTE) in patients undergoing elective total hip replacement, and the other was a Phase IIb study of a drug to prevent VTE following elective total knee replacement.

Corces also was cited for violating trial protocols. Although one protocol said only birth control pills or the barrier method were acceptable forms of control for trial subjects, an 18-year-old woman was “encouraged to practice abstinence for at least three months after having the surgical procedure,” an instruction the FDA deemed unacceptable, according to the letter.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/s6837c.htm.