The Regulatory Affairs Core (RAC) is jointly led by the regulatory teams at the University of California, San Francisco and the University of Pittsburgh, in conjunction with CHeT CTCC and other regulatory consultants, with responsibility for overseeing collaboration with the U.S. Food and Drug Administration, drug manufacturers, sponsors, and TRACK-TBI NET investigators. The RAC maintains and updates timelines for progress toward regulatory milestones and prepares for and leads discussions with FDA regarding protocol development and amendments. The RAC also takes a lead role, in collaboration with the Outcomes Core, BAC, and participating drug manufacturers and sponsors, in producing study reports and other regulatory documentation formatted for FDA review.
