Drug Development Support for the CTEP

为了确保癌症治疗评估计划(CTEP)能够履行其作为IND赞助商的责任，CTEP抗癌研究药物开发支持合同向CTEP研究药物处(IDB)和监管事务部(RAB)提供与这些责任相关的多个领域的援助。这些工作包括：1)协助起草和组织研究用新药申请(IND)；2)复制所有IND提交的材料并提交给FDA和合作者；3)维护ND修正案提交、规程、FDA通信跟踪、合作研究和开发协议(CRADAS)、临床试验协议(CTA)以及IND状态的数据库；4)接收、处理和执行对不良反应的初步评估，必要时要求适当的补充数据，并准备书面不良事件报告提交FDA，并将副本提交给药物合作者。

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.