Drug Development Support for the Cancer Therapy Evaluation Program (CTEP)

为了确保癌症治疗评估计划 (CTEP) 能够履行其作为 IND 申办者的职责，CTEP 研究抗癌药物开发支持合同为 CTEP 研究药物部门 (IDB) 和监管事务部门 (RAB) 在与这些职责相关的许多领域提供协助。其中包括 1) 协助起草和组织新药研究申请 (IND)； 2) 制作所有 IND 提交的副本并将其交付给 FDA 以及合作者 3) 维护 ND 修订提交、方案、FDA 通信跟踪、合作研究和开发协议 (CRADA) 和临床试验协议 (CTA) 以及 IND 状态的数据库； 4) 接收、处理和执行不良事件的初步评估，如果需要，请求适当的补充数据，并准备书面不良事件报告提交给 FDA，并将副本发送给制药合作者。

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 agents 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.