Home » Reproductive Center Warned for Problems in Device Trial
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
Clinical Trials Advisor
Upcoming Events
-
25Apr
-
07May
-
14May
-
30May