THE CONTRACTOR SHALL PROVIDE SUPPORT TO THE CTEP, INVESTIGATIONAL DRUG BRANCH (I

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The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is responsible for administration and coordination of most of the extramural clinical trials supported by the DCTD. CTEP is also responsible for the development of more than 100 investigational agents on which the Division has filed more than 125 Investigational New Drug Applications (INDs) with the Food and Drug Administration (FDA). The CTEP must prepare, file and manage INDs for the investigational agents it sponsors in clinical trials, including the agents from the NCI's intramural clinical programs. This includes INDs to support the new Division initiative with the Center for Cancer Research for Joint Development Committee (JDC), Exploratory IND/Phase 0 and Rapid Access to Intervention Development (RAID) agents. As the sponsor of these agents, DCTD must design a plan for the efficient evaluation and development of these agents and monitor the safety, efficacy and distribution of the agents in the trials, tracking the progress of the studies both administratively and scientifically, reporting adverse events in an expedited manner and preparing IND annual reports for submission to the FDA, and other special reports and manuscripts. The CTEP must also submit amendments to the INDs it sponsors including new protocols, protocol amendments, adverse events, updated chemistry and manufacturing information, compassionate exemptions, responses to FDA communications, etc. The Contractor shall provide support for a wide range of services related to these responsibilities including the role of CTEP in meeting FDA regulatory requirements. Other related functions may be assigned as they develop over the life of the contract. To assist the Investigational Drug Branch (IDB) in fulfilling its responsibilities as IND Safety Monitors, the services of a Contractor continue to be required to provide support for: 1) investigational agent development and clinical research information management; 2) information and data collection/compilation, maintenance and retrieval, technical report and manuscript preparation, reports to support monitoring of clinical activities, administrative coordination, and general logistical support of investigational agent development; and 3) maintenance of up to date project plans and maintain databases relating to various aspects of agent development, and initial review of serious adverse events, requesting appropriate supplemental data and preparation of reports to FDA and investigators. To assist the Regulatory Affairs Branch (RAB) in meeting its responsibilities as a representative of the IND sponsor and collaboration with pharmaceutical companies, the services of a Contractor continue to be required to provide support for: 1) assistance in writing and organizing Investigational New Drug Applications (INDs) (approximately 15-30 per year) from data provided by RAB; 2) making copies of all IND submissions and delivering them to the FDA and collaborators; 3) maintaining existing databases for the RAB database (IND amendment submissions, protocols, etc.); and 4) maintaining additional databases for FDA communications tracking, Cooperative Research and Development Agreements (CRADAs), Clinical Trials Agreements (CTAs) and other clinical and non-clinical agreements as well as IND status.