BASE PERIOD 03/08/2013 - 09/07/2013 STORAGE AND DISTRIBUTION OF CLINICAL AGENTS H

基期 03/08/2013 - 09/07/2013 临床制剂 H 的储存和分发

• 批准号: 8844807
• 负责人: YOUNG KIM
• 金额: $ 288.98万
• 依托单位: FISHER BIOSERVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-03-08 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8844807
• 关键词: Accounting; Cancer Center; Clinical; Clinical Distribution; Clinical Trials; Contractor; Contracts; Controlled Clinical Trials; Double-Blind Method; Equipment and supply inventories; Fire - disasters; Funding; Institution; Label; Malignant Neoplasms; Monitor; National Cancer Institute; New Agents; Patients; Pharmacologic Substance; Physicians; Placebo Control; Preclinical Drug Development; Process; Records; Regulation; Secure; Services; Specific qualifier value; System; Temperature; base; cancer diagnosis; cancer therapy; computerized; open label; programs; repository; research and development

The Contractor maintains and operates the NCI Clinical Repository for the Cancer Therapy EvaluationProgram,Division of Cancer Treatment and Diagnosis, NCI. This contract is responsible for the receipt, storage,distribution and final disposition of hundreds of clinical investigational agents. The Contractor must maintain specialexpertise in the management, labeling and distribution of clinical supplies for double-blind placebo-controlled clinicaltrials. The Contractor receives and inspects agents according to applicable regulations as they are received frommanufacturers and suppliers throughout the world. Agents are inventoried and stored in a secured, monitored, fire-protected warehouse under specified environmental and controlled temperature conditions. Computerized recordkeeping accompanies each step of the process through receipt, storage, distribution, and final disposition of each unitof agent using the Pharmaceutical Management Branch computerized inventory system.

承包商维护并运营NCI临床存储库，用于癌症治疗评估程序，癌症治疗和诊断司，NCI。该合同负责数百名临床研究代理的收据，存储，分配和最终处置。承包商必须在管理，标记和分布双盲安慰剂控制的临床临床临床供应中保持特定的临床供应。承包商根据适用的法规接收并检查代理商，因为它们是全球从制造商和供应商那里获得的。代理商在特定的环境和受控温度条件下库存并存储在有害，受监控，受到火灾保护的仓库中。计算机记录保存通过使用药品管理分支机构计算机库存系统的每个单位代理的收据，存储，分配和最终处置来伴随流程的每个步骤。