Reproductive Center Warned for Problems in Device Trial

Problems with informed consent, protocol deviations and failure to submit progress reports are cited in a warning letter to Daniel Potter, an investigator at Huntington Reproductive Center Medical Group. The letter stems from a June inspection of the Laguna Hills, Calif., site, which participated in a clinical trial studying the safety and effectiveness of an investigational device to support a premarket approval application. In several instances, patients participating in the trial signed incorrect versions of the informed consent form that were not approved by the IRB, according to the Nov. 2 letter.
Clinical Trials Advisor