In order to assure that the Cancer Therapy Evaluation Program (CTEP) is able to fulfill its responsibilities as an IND sponsor, the CTEP Drug Development Support Contract for investigational anti-cancer provides the CTEP Investigational Drug Branch (IDB) and the Regulatory Affairs Branch (RAB) with assistance in a number of areas related to these responsibilities. These include 1) assistance in drafting and organizing Investigational New Drug Applications (INDs); 2) making copies of all IND submissions and delivering them to the FDA, as well as collaborators 3) maintaining databases for ND amendment submissions, protocols, FDA communications tracking, Cooperative Research and Development Agreements (CRADAs) and Clinical Trials Agreements (CTAs) as well as IND status; 4) receiving, processing, and performing an initial assessment of AEs, requesting appropriate supplemental data if required and preparing written adverse event reports for submission to the FDA, with copies to pharmaceutical collaborators.
