SAFETY DESK

The TIMI Study Group provides safety reporting and event review services for several on-going trials including several large phase III multinational studies. The TIMI Safety Desk works as an integral part of trial operations in order to facilitate the timely, accurate, and complete reporting of safety events and events of special interest throughout the course of the trial. Tasks performed by the Safety Desk include safety event processing, source document review, listing reviews, medical monitoring and review, and site support regarding the accurate reporting of events. The TIMI Safety Desk uses standardized procedures and automated processes to insure consistent case processing that is consistent with all regulatory mandates. TIMI Safety works closely with TIMI and Sponsor Trial Operations and the TIMI CEC to identify potential sentinel events as well as potential missed safety or efficacy events. In general, TIMI Safety works as an intermediary between the sites and the sponsor safety group to review events and facilitate accurate reporting by the sites.