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）设施将：a）为UAB癌症中心教师和我们与SPORE、其他癌症中心、NCI、行业和合作团体相关的校外合作者开发的临床试验的实施、协调和开展提供集中管理，B）提供操作的质量保证，包括毒性监测、临床护理、数据收集，并遵守方案描述的程序，c）提供方案特定数据的集中数据库，d）根据方案和监管机构（当地、州和国家）的要求，为方案患者使用的所有研究药物的采集、储存、分发和跟踪提供研究药物支持。 自上次提交以来的主要成就包括：a）CPDM机构的4年累积患者增加了28%。 该患者招募包括总计1047例患者参加研究者发起的试验（34%）。 总招募人数）和1305例患者参加I期和II期试验（总应计费用的42%），B）实施临床试验监测委员会（CTMC），该委员会每周开会并监测癌症中心的每一项活跃的临床试验，c）发展由护士方案协调员和数据管理员组成的专门方案管理团队，以提高其疾病特异性专业知识，加强护士与医生之间的互动，增加高优先级研究中招募的患者数量，d）在此资助期间，癌症中心在招募16名临床研究人员到UAB临床部门和部门中发挥了核心作用。 这些招聘包括癌症中心副主任（Bland博士）、临床研究副主任（Rinehart博士）和CPDM机构医学主任（Forero博士）。 e）2002年，在Carla Falkson医学博士的领导下，我们发展成为了ECOG的正式成员。 2003年，我们成为正式会员的第一年，我们成为ECOG的领先累积网站，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.