OTHER FUNCTIONS SUPPORT SERVICES FOR THE PHARMACEUTICAL MANAGEMENT BRANCH

药品管理部门的其他职能支持服务

• 批准号: 8563076
• 负责人: ARIE GRAY
• 金额: $ 135.31万
• 依托单位: EDJ ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-05-01 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8563076
• 关键词: Agreement; Authorization documentation; Cancer Therapy Evaluation Program; Clinical; Clinical Trials; Contractor; Division of Cancer Treatment and Diagnosis; Equipment and supply inventories; Government; Location; Maintenance; Maryland; National Cancer Institute; Pamphlets; Pharmaceutical Services; Pharmacologic Substance; Protocols documentation; Research Personnel; Site; cancer diagnosis; cancer therapy; programs

The Pharmaceutical Management Branch (PMB), Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment and Diagnosis (DCTD) provides comprehensive support for the management and distribution of investigational agents for CTEP sponsored clinical trials. This support includes, but is not limited to, acquisition, inventory management, order authorization and record maintenance for all CTEP IND agents and a limited number of commercially available agents distributed under Clinical Supplies Agreements. PMB also oversees the distribution of confidential Investigator Brochures for our IND agents. PMB maintains registration required for investigators to participate in protocols sponsored by multiple programs within the DCTD. PMB provides comprehensive pharmaceutical information and pharmaceutical review for protocols sponsored by programs throughout the DCTD.

癌症治疗和诊断部（DCTD）癌症治疗评价项目（CTEP）的药物管理分支（PMB）为CTEP申办的临床试验的研究药物的管理和分配提供全面支持。该支持包括但不限于所有CTEP IND制剂和根据临床供应协议分销的有限数量市售制剂的采购、库存管理、订单授权和记录维护。港口及航运局还监督我们的IND代理商的机密研究者手册的分发。PMB维护研究者参与DCTD内多个项目申办的方案所需的注册。港口及航运局提供全面的药物信息和药物审查的方案主办的整个DCTD。