SUPPORT SERVICES FOR THE PHARMACEUTICAL MANAGEMENT BRANCH

药品管理部门的支持服务

• 批准号: 8065563
• 负责人: ARIE GRAY
• 金额: $ 124.88万
• 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/8065563
• 关键词: Accounting; Authorization documentation; Cancer Therapy Evaluation Program; Charge; Clinical; Clinical Trials; Contractor; Data; Development; Division of Cancer Treatment and Diagnosis; Equipment; Equipment and supply inventories; Evaluation; Extramural Activities; Government; Human Resources; Location; Maintenance; Malignant Neoplasms; National Cancer Institute; Pharmaceutical Services; Pharmacists; Pharmacologic Substance; Photocopying; Process; Protocols documentation; Reporting; Research; Research Personnel; Resources; Retrieval; Scanning; Site; Support Contracts; Telefacsimile; Telephone; Time; Treatment Referral Center Protocol; Word Processing; Work; cancer therapy; drug development; information organization

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）癌症治疗与诊断部（DCTD）、癌症治疗评估项目（CTEP）药物管理处（PMB）负责为国家癌症研究所资助的临床试验提供全面的药物支持。DCTD赞助校内和校外研究，用于临床开发和评估潜在有效的癌症治疗方法。PMB支持合同的目的是促进CTEP支持的临床试验中提供的所有药物的管理和分销，包括库存控制、订单授权和相关文件管理。承包商还管理参与NCI赞助的癌症临床试验的研究者和相关注册流程。它们还管理企业核心模块（ECM）和相关的帮助台。ECM为CTEP提供参与临床试验的人员和组织信息的实时维护（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赞助的临床试验的助理和研究人员提供用户帐户和访问权限。承包商还通过提供有关药物使用的必要报告来支持PMB药剂师，以促进对其药物组合的适当管理。承包商通过特殊例外和/或治疗转诊中心协议，促进研究药物的授权和分发，使研究药物能够在协议之外/出于同情的情况下使用。除了提供上文所述的必要支援资源外，承办商亦提供文字处理、数据输入、影印、档案、电话、传真、扫描及其他文书支援服务。承包商提供并维护一个场外场所，包括该场所所需的所有设备，用于其他人员和文件存储。一般来说，调查员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。