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

癌症治疗与诊断部(DCTD)、国家癌症研究所(NCI)的癌症治疗评估计划(CTEP)负责管理和协调由DCTD支持的大多数外部临床试验。CTEP还负责开发100多种研究药物，该司已向食品和药物管理局(FDA)提交了125多份研究新药申请(IND)。CTEP必须为其在临床试验中赞助的研究代理准备、归档和管理IND，包括来自NCI内部临床计划的代理。这包括INDS支持与癌症研究中心联合开发委员会(JDC)、探索性IND/0期和快速获得干预开发(RAID)试剂的新部门倡议。作为这些药物的赞助商，DCTD必须为这些药物的有效评估和开发设计一个计划，并监测这些药物在试验中的安全性、有效性和分布，从行政和科学两方面跟踪研究的进展，加速报告不良事件，准备IND年度报告提交给FDA，以及其他特别报告和手稿。CTEP还必须提交对其赞助的INDS的修正案，包括新方案、方案修正案、不良事件、更新的化学和制造信息、同情豁免、对FDA通信的回应等。承包商应为与这些责任相关的广泛服务提供支持，包括CTEP在满足FDA法规要求方面的作用。其他相关职能可根据合同有效期内的发展情况进行分配。 为协助毒品调查处履行其作为禁毒处安全监督员的职责，继续需要一名承包商的服务，以提供以下支助： 1)研究药物开发和临床研究信息管理； 2)信息和数据收集/汇编、维护和检索、技术报告和手稿编写、支持监测临床活动的报告、行政协调和研究试剂开发的一般后勤支助；以及 3)维护最新的项目计划，维护与试剂开发的各个方面有关的数据库，以及对严重不良事件的初步审查，要求提供适当的补充数据，并编写提交给FDA和调查人员的报告。 为协助管制事务处履行其作为IND赞助商代表的职责以及与制药公司的合作，继续需要承包商的服务，以提供以下方面的支持： 1)根据RAB提供的数据，协助编写和组织新药研究申请(IND)(每年约15-30份)； 2)复制所有IND提交的材料，并将其提交给FDA和合作者； 3)维护RAB数据库的现有数据库(IND修正案提交、协议等)；以及 4)维护FDA通信跟踪、合作研究和开发协议(CRADAS)、临床试验协议(CTA)和其他临床和非临床协议以及IND状态的额外数据库。

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.