CLINICAL PROTOCOL AND DATA MANAGEMENT

描述(由申请人提供)：临床方案和数据的总体目标 管理共享(CPDM)设施是：a)为实施、协调和实施由UAB癌症中心教员和我们与孢子相关的外部合作者、其他癌症中心、NCI、工业和合作团体开发的临床试验提供中央管理；b)提供操作的质量保证，包括监测毒性、临床护理、数据收集和遵守方案描述的程序；c)提供特定方案数据的集中数据库；以及d)根据方案和管理机构(地方、州、和国家)。自上次提交以来取得的主要成就包括：a)CPDM设施中患者的4年应计收入增加了28%。这一患者收益包括总共1047名患者参加调查者发起的试验(34% (B)实施临床试验监测委员会(CTMC)，该委员会每周召开会议，监督癌症中心的每项现行临床试验；(C)建立由护士规程协调员和数据管理员组成的专门规程管理团队，以改进他们对疾病的专门知识，加强护士与医生的互动，并增加参加重点研究的患者人数；d)在此资助期间，癌症中心在向UAB临床科室招募16名临床研究人员方面发挥了核心作用。这些招聘人员包括癌症中心副主任(Bland博士)、临床研究副主任(Rinehart博士)和CPDM机构的医学主任(Forero博士)。E)2002年，在医学博士Carla Falkson的领导下，我们发展了ECOG的正式成员资格。2003年，也就是我们正式成员的第一年，我们成为ECOG的主要应计网站，注册人数超过100人。

DESCRIPTION (provided by applicant): The overall aims of the Clinical Protocol and Data Management Shared (CPDM) Facility are to: a) provide central management for the implementation, coordination, and conduct of clinical trials developed by the UAB Cancer Center faculty and by our extramural collaborators associated with SPOREs, other Cancer Centers, the NCI, industry and cooperative groups, b) provide for quality assurance of the operation including monitoring of toxicities, clinical care, data collection, and adherence to protocol-described procedures, c) provide a centralized database of protocol-specific data, and d) provide research pharmacy support for the acquisition, storage, dispensing, and tracking of all investigational agents administered to protocol patients as required by the protocol and regulatory agencies (local, state, and national). Major accomplishments since last submission have included: a) An increment of 28% in the 4 year accrual of patients in the CPDM Facility. This patient accrual includes a total of 1047 patients to investigator initiated trials (34% of the total accrual) and 1305 patients to Phase I and II trials (42% of the total accrual), b) Implementation of the Clinical Trials Monitoring Committee (CTMC) which meets weekly and monitors every active clinical trial in the Cancer Center, c) Development of specialized Protocol Management Teams consisting of nurse protocol coordinators and data managers to improve their disease specific expertise, enhance nurse-physician interaction and to increase the number of patients enrolled in the high priority studies, d) During this funding period, the Cancer Center played a central role in recruitment of 16 clinical investigators to UAB clinical Divisions and Departments. These recruitments ncluded the Deputy Director of the Cancer Center (Dr. Bland), Associate Director for Clinical Research (Dr. Rinehart) and Medical Director of the CPDM Facility (Dr. Forero). e) In 2002, we developed full ECOG membership under the leadership of Carla Falkson, M.D. In 2003, our first year of full membership we became the leading accrual site for ECOG with over 100 registrations.