IND safety reporting: final results and best practices, from the Clinical Trials Transformation Initiative IND Safety Advancement Project.

2531Background: As clarified in 2010, the FDA IND Safety Reporting Regulation requires sponsors to review safety data across all studies in an IND, analyze data in aggregate, assess causality, and issue reports only when it is reasonably likely that serious, unexpected event(s) were caused by the drug. A 2016 FDA analysis demonstrates that the number of expedited reports per IND per year is increasing and most reports (86%) are uninformative. We sought to understand 1) sponsor challenges to full implementation of the Regulation, 2) sponsor motivation to change safety reporting practice, 3) investigator site safety report management, and 4) best practices for communicating safety reports. Methods: Surveys of sponsors (n = 28) and investigator sites (n = 201) were conducted, followed by interviews. Best practices were shared at a July 2015 Expert Meeting. Results: Surveys of sponsors (n = 28) and investigator sites (n = 201) were conducted, followed by interviews. Best practices were shared at a July 2015 E...