We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » Device Investigator Warned for Improper Consent
Device Investigator Warned for Improper Consent
September 2, 2009
An investigator in a device clinical trial had subjects sign an outdated informed consent form, did not document his annual progress reports and did not keep adequate device receipt and disposition records, according to an FDA warning letter.