SUPPORT SERVICES FOR CTEP

CTEP 的支持服务

• 批准号: 3614829
• 负责人: ROBERT VIT
• 金额: $ 22.33万
• 依托单位: SOCIAL AND SCIENTIFIC SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-04-01 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3614829
• 关键词: chemical information system; drug adverse effect; human therapy evaluation; neoplasm /cancer chemotherapy; neoplasm /cancer pharmacology

The contract provides support services for the operations of the Cancer Therapy Evaluation Program, particularly the Investigational Drug Branch, Regulatory Affairs Branch, Biometric Research Branch and the Protocol and Information Office. The contractor is responsible for the data collection/compilation, technical report preparation, monitoring of clinical activities, administrative coordination, and general logistical support, particularly in the area of investigational drugs which are subject to regulation by the Food and Drug Administration (FDA). The contract is divided into two principal parts: A. Clinical Research/FDA compliance support which includes: a) Clinical Research Support b) Regulatory Affairs Support c) Drug Distribution Support B. Protocol and Information Support which includes: a) Protocol Review and Approval b) Protocol Information Tracking and Dissemination c) Protocol Results and Publications

合同为癌症的运作提供支持服务 治疗评估计划，特别是研究药物分支 监管事务部门，生物识别研究分支和协议以及 信息办公室。 承包商负责数据 收集/汇编，技术报告准备，监视 临床活动，行政协调和一般后勤 支持，特别是在研究药物领域 受美国食品药品监督管理局（FDA）的监管。 合同分为两个主要部分： A.临床研究/FDA合规性支持，其中包括： a）临床研究支持 b）监管事务支持 c）药物分配支持 B.协议和信息支持，其中包括： a）协议审查和批准 b）协议信息跟踪和传播 c）协议结果和出版物