Clinical Protocol Management

临床方案管理

• 批准号: 7714131
• 负责人: THEODORE G KRONTIRIS
• 金额: $ 9.3万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2012-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7714131
• 关键词: Adherence; Administrator; Adoption; Adverse event; Adverse reactions; Area; Arizona; Budgets; Calendar; California; Cancer Center; Cancer Center Support Grant; Career Ladders; Cell Transplantation; Cities; Clinical; Clinical Practice Guideline; Clinical Protocols; Clinical Research; Clinical Research Associate; Clinical Trials; Collaborations; Communicable Diseases; Conduct Clinical Trials; Continuing Education; Daily; Data; Data Collection; Data Quality; Development; Disease; Doctor of Philosophy; Documentation; Education; Eligibility Determination; Enrollment; Ensure; Equilibrium; Evaluation; Fees; Goals; Hematology; Housing; Individual; Information Management; Information Sciences; Informed Consent; Internet; Investigational Drugs; Maintenance; Malignant Neoplasms; Medical; Medical Oncology; Mentors; Monitor; Names; National Surgical Adjuvant Breast and Bowel Project; Nature; Operative Surgical Procedures; Outcomes Research; Patient Care; Patients; Pediatrics; Peer Review; Performance; Performance Status; Phase; Policies; Population Sciences; Preparation; Procedures; Protocols documentation; Publications; Quality Control; Radiation Oncology; Radioimmunotherapy; Reaction; Reporting; Research Ethics Committees; Research Personnel; Research Support; Resource Sharing; Resources; Services; Site; Source; Specialist; Standards of Weights and Measures; Supervision; Surgical Oncology; Training; United States Food and Drug Administration; Workload; anticancer research; cancer diagnosis; data management; design; drug development; follow-up; member; neuro-oncology; outreach; outreach program; programs; quality assurance

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).

临床方案管理核心（CPMC）的目标是提供方案管理和数据 管理服务。CPMC由Joyce Niland博士指导，癌症中心副主任， 信息科学和主席，信息科学部（DIS）;核心经理是迪娜约翰逊， DIS内临床研究信息管理部主任。具体服务包括 为研究方案和数据管理问题提供输入和审查，确认患者合格性 研究登记、管理进行中的研究、收集研究数据、监测监管 依从性，协助IRB提交，确保及时报告不良反应，协助 为研究分析准备数据，参加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。CPMC 工作人员为City of Hope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（HCT），内科肿瘤学，外科肿瘤学，儿科，感染 疾病，神经肿瘤学，放射免疫治疗，放射肿瘤学，人口科学。CPMC还 为NSABP外展计划提供数据协调服务，第11阶段\\新药开发 通过加州癌症联盟匹兹堡试验，COH帕萨迪纳外展办公室，和 亚利桑那州好撒玛利亚人HCT计划。CPMC临床研究协会的日常监督 （CRA）由核心经理/部门总监和两名临床试验管理员提供， 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价。运营专家协助制定政策和程序， 临床试验在线网站的设计、方案报告和维护。高级数据输入 书记员提供方案数据和方案特定结果的输入。在2006财年，CPMC 为551项癌症相关规程提供了上述服务。2，073名患者累积至 由CPMC管理的方案，随访7，854例患者。从2002年至2006年，出版了170多种出版物， 癌症研究报告使用了由CPMC收集和质量控制的数据。期间 在2006财政年度报告期间，来自5个项目的64名癌症中心成员使用了CPMC。同行审查 使用量占总CPMC使用量的92.5%（1，918/2，073例患者累积）。年度预算 核心预算为5，308，224美元，包括25%的机构支助、5%的使用费和68%的其他费用。CCSG 要求2%（13.1万美元）。