"No 483 for Me" - iOS App
Background
"Clinical trial noncompliance has always been an industry concern. According to the FDA, the most common compliance deficiencies during inspections include inadequate investigator oversight, protocol deviations, poor record keeping, insufficient investigational product accountability, and issues with subject protection and consenting. Unfortunately, many study sites consistently face these challenges, and are still charged with 483s. William (Bill) Tobia, M.S., M.B.A., recently developed the “No 483 for Me” app as a preventative measure to help study sites avoid common noncompliance practices during clinical trial conduct."
Applied Clinical Trials, August 1, 2016
