SUPPORT SERVICES FOR THE PHARMACEUTICAL MANAGEMENT BRANCH

药品管理部门的支持服务

• 批准号: 7933266
• 负责人: ARIE GRAY
• 金额: $ 139.92万
• 依托单位: EDJ ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2012-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7933266
• 关键词: SUPPORT; SERVICES; PHARMACEUTICAL; MANAGEMENT; BRANCH

The Pharmaceutical Management Branch (PMB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), is charged with providing comprehensive pharmaceutical support for clinical trials sponsored by the National Cancer Institute. The DCTD sponsors intramural and extramural research for the clinical development and evaluation of potentially effective cancer treatments. The purpose of the PMB support contract is to facilitate the management and distribution of all agents supplied on CTEP supported clinical trials with respect to inventory control, order authorization, and associated document management. The contractor also manages the investigator and associate registration processes for participation in NCI sponsored cancer clinical trials. They also manage the Enterprise Core Module (ECM) and associated Help Desk. The ECM serves CTEP in the real-time maintenance (i.e., data entry, storage, reporting, analysis, retrieval) of people and organization information for those who participate on clinical trials. The information is collected from both remote investigator sites and CTEP offices and branches. Additional responsibilities include management of the Access Identity Maintenance (AIM) module which provides user accounts and access to Associates and Investigators participating in NCI-sponsored clinical trials. The contractor also supports the PMB pharmacists by providing the necessary reports concerning agent usage to facilitate the proper management of their portfolio of agents. The contractor facilitates the authorization and distribution of investigational agents for off-protocol/compassionate access to investigational agents via the Special Exception and/or Treatment Referral Center Protocols. In addition to providing the PMB with the necessary support resources as outlined above, the contractor provides word processing, data entry, photocopying, filing, telephone, faxing, scanning, and other clerical support. The contractor provides and maintains an off-site location including all equipment necessary at that site, for other personnel and file storage. In very general terms, Investigator and Associate registration work is done at the contractor site and agent related activities are handled at the government site.

国家癌症研究所（NCI）癌症治疗和诊断部（DCTD）癌症治疗评估项目（CTEP）药物管理分支（PMB）负责为国家癌症研究所申办的临床试验提供全面的药物支持。DCTD赞助校内和校外研究，用于潜在有效癌症治疗的临床开发和评估。PMB支持合同的目的是在库存控制、订单授权和相关文件管理方面促进CTEP支持的临床试验中提供的所有药物的管理和分发。承包商还负责管理研究者和参与NCI申办的癌症临床试验的助理注册流程。他们还管理企业核心模块（ECM）和相关的帮助台。ECM在实时维护中为CTEP服务（即，数据输入、存储、报告、分析、检索）的人和组织信息。从远程研究中心和CTEP办公室和分支机构收集信息。其他职责包括管理访问身份维护（AIM）模块，该模块为参与NCI申办的临床试验的助理和研究者提供用户帐户和访问权限。承包商还支持港口及航运局药剂师提供必要的报告，有关代理的使用，以促进其代理组合的适当管理。承包商通过特殊例外和/或治疗转诊中心方案，促进研究药物的授权和分发，以获得研究药物的方案外/同情访问。除了向港口及航运局提供上述必要的支助资源外，承包商还提供文字处理、数据输入、复印、归档、电话、传真、扫描和其他文书支助。承包商提供并维持一个场外地点，包括该地点的所有必要设备，供其他人员和档案储存之用。一般而言，研究者和助理注册工作在承包商现场完成，代理相关活动在政府现场处理。