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: 10002146
• 负责人: ARIE GRAY
• 金额: $ 3.79万
• 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 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10002146
• 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; Investigation; Location; Maintenance; Maryland; National Cancer Institute; Pamphlets; Pharmaceutical Services; Pharmacologic Substance; Protocols documentation; Research Personnel; Site; 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.

癌症治疗与诊断部（DCTD）癌症治疗评估项目（CTEP）的药物管理分部（PMB）为CTEP赞助的临床试验的研究药物的管理和分配提供全面支持。这种支持包括但不限于所有CTEP IND制剂和根据临床供应协议分发的有限数量的市售制剂的采购、库存管理、订单授权和记录维护。PMB还负责为我们的IND特工分发保密的调查员手册。PMB要求调查人员参加由DCTD内多个项目赞助的协议。PMB为整个DCTD项目赞助的方案提供全面的药物信息和药物审查。