Clinical Protocol Management

临床协议管理核心(CPMC)的目标是提供协议管理和数据 管理服务。CPMC由Joyce Nland，博士，癌症中心副主任 信息科学和信息科学部(DIS)主席；核心经理是Dina Johnson， DIS临床研究信息管理部主任。具体服务包括 为方案和数据管理问题提供输入和研究审查，确认患者资格 和注册研究，管理正在进行的研究，收集研究数据，监测监管 合规，协助提交IRB，确保及时报告不良反应，协助 为研究分析准备数据，并参与继续教育和质量保证 程序。所有这些都是按照FDA良好临床实践(GCP)进行的。中巴经济合作委员会 工作人员为希望之城的所有临床部门提供研究支持，包括血液学和 造血细胞移植、内科肿瘤学、外科肿瘤学、儿科学、感染学 疾病、神经肿瘤学、放射免疫疗法、放射肿瘤学、人口科学。中国人民政治协商会议还 为NSABP推广计划第11阶段新药开发提供数据协调服务 通过加州癌症联合会-匹兹堡试验、COH帕萨迪纳外展办公室和 亚利桑那州好心人HCT计划。CPMC临床研究协会的日常监督 (CRAS)由核心经理/部门主任和两名临床试验管理员提供 向她报告。质量控制协调员协助培训、审查数据和执行方案 内部试验的依从性评估。运营专家协助制定政策、程序、表格 临床试验在线网站的设计、方案报告和维护。两个高级数据录入 办事员提供协议数据的输入以及协议特定的结果。2006财年，CPMC 为551项癌症相关方案提供上述服务。2073名患者被累积到 由CPMC管理的方案，有7854名患者在随访。2002-2006年间出版了170多种出版物和 癌症研究报告利用了CPMC收集的数据和质量控制。在.期间 在2006财年报告期间，癌症中心的5个项目的成员使用了CPMC。同行评审 使用量占CPMC总使用量的92.5%(1,918/2,073名患者应计)。年度预算 核心费用为5,308,224美元，其中包括25%的机构支持，5%的用户费用和68%的其他费用。CCSG 要求2%(131,000美元)。

The goal of the Clinical Protocol Management Core (CPMC) is to provide protocol administration and data management services. The CPMC is directed by Joyce Niland, PhD, Cancer Center Associate Director for Information Sciences and Chair, Division of Information Sciences (DIS); the Core Manager is Dina Johnson, Director of the Clinical Research Information Management Department within DIS. Specific services include providing input and review of studies for protocol and data management issues, confirming patient eligibility and registration on study, managing studies in progress, collecting study data, monitoring regulatory compliance, assisting with IRB submissions, ensuring timely reporting of adverse reactions, assisting with preparation of data for study analyses, and participating in continuing education, and quality assurance procedures. All of these are carried out in compliance with FDA Good Clinical Practices (GCP). The CPMC staff provides research support for all clinical departments at City of Hope, including Hematology & Hematopoeitic Cell Transplantation (HCT), Medical Oncology, Surgical Oncology, Pediatrics, Infectious Disease, Neuro-oncology, Radioimmunotherapy, Radiation Oncology, Population Sciences. The CPMC also provides data coordinating services for the NSABP Outreach Program, Phase 11\\ new drug development through the California Cancer Consortium-Pittsburgh trials, the COH Pasadena Outreach Office, and the Arizona Good Samaritan HCT Program. Daily supervision of the CPMC Clinical Research Associates (CRAs) is provided by the Core Manager/Department Director and two Clinical Trial Administrators who report to her. Quality Control Coordinators assist in training, reviewing data, and conducting Protocol Adherence Evaluations of in-house trials. Operations Specialists assist with policies and procedures, forms design, protocol reporting and maintenance of the Clinical Trials On-Line Web site. Two Senior Data Entry Clerks provide entry of protocol data as well as protocol specific results. In Fiscal Year (FY) 2006, CPMC provided the abovementioned services for 551 cancer-related protocols. 2,073 patients were accrued to protocols managed by CPMC, with 7,854 patients in follow-up. From 2002-2006 over 170 publications and cancer research presentations utilized data collected and quality controlled by the CPMC. During the FY2006 reporting period, the CPMC was utilized by 64 Cancer Center members from 5 programs. Peerreviewed usage represented 92.5% (1,918/2,073 patient accruals) of the total CPMC usage. Annual budget for the core is $5,308,224, comprising 25% institutional support, 5% user fees, and 68% other. The CCSG request is for 2% ($131,000).