FDA 483 - Impact Clinical Trials - February 11, 2010

An FDA inspection of Impact Clinical Trials in Los Angeles, CA, revealed significant deficiencies in their conduct of clinical trials. The firm failed to ensure proper informed consent, including not providing critical errata to numerous subjects and using unreadable consent forms. Additionally, the inspection found issues with investigator oversight, as sub-investigators were not properly listed on FDA-1572 forms or did not sign required financial disclosure forms.