SUPPORT SERVICES FOR THE PHARMACEUTICAL MANAGEMENT BRANCH

药物管理处(PMB)、癌症治疗评估计划(CTEP)、癌症治疗和诊断部(DCTD)、国家癌症研究所(NCI)负责为国家癌症研究所赞助的临床试验提供全面的药物支持。DCTD赞助临床开发和评估潜在有效的癌症治疗的内部和外部研究。PMB支持合同的目的是促进在库存控制、订单授权和相关文件管理方面为CTEP支持的临床试验提供的所有代理的管理和分发。承包商还管理参与NCI赞助的癌症临床试验的研究人员和副注册程序。他们还管理企业核心模块(ECM)和相关的帮助台。ECM为CTEP提供服务，为参与临床试验的人员和组织信息提供实时维护(即，数据输入、存储、报告、分析、检索)。这些信息是从远程调查员站点和CTEP办公室和分支机构收集的。其他职责包括管理访问身份维护(AIM)模块，该模块为参与NCI赞助的临床试验的同事和研究人员提供用户帐户和访问权限。承包商还向港口及航运局药剂师提供有关药剂使用情况的必要报告，以协助适当管理他们的药剂组合。承包商通过特殊例外和/或治疗转诊中心协议，促进授权和分发调查代理，以非礼仪/同情方式访问调查代理。除了如上所述向港口及航运局提供必要的支助资源外，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。承包商提供并维护一个非现场位置，包括该现场所有必要的设备，以供其他人员和文件存储。一般而言，调查员和助理的注册工作在承建商工地进行，与代理人有关的活动则在政府工地处理。

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.