Clinical Protocol Management

临床方案管理

基本信息

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
项目类别：
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

项目摘要

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、癌症中心副主任指导信息科学和信息科学部 (DIS) 系主任；核心经理是迪娜·约翰逊， DIS 临床研究信息管理部主任。具体服务包括提供研究方案和数据管理问题的输入和审查，确认患者的资格研究和注册、管理正在进行的研究、收集研究数据、监测监管合规性，协助 IRB 提交，确保及时报告不良反应，协助准备研究分析数据、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。 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)、肿瘤内科、肿瘤外科、儿科、感染科疾病、神经肿瘤学、放射免疫治疗、放射肿瘤学、人口科学。中粮监委还为 NSABP 外展计划第 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临床研究员的日常监督（CRA）由核心经理/部门主管和两名临床试验管理员提供，他们向她报告。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。 2.高级数据录入职员提供协议数据的输入以及协议特定的结果。 2006财年（FY），中粮包装为551个癌症相关方案提供了上述服务。累计 2,073 名患者由 CPMC 管理的方案，有 7,854 名患者接受随访。从 2002 年到 2006 年，发表了超过 170 篇出版物癌症研究报告利用了 CPMC 收集的数据和质量控制。期间 2006 财年报告期间，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 请求金额为 2%（131,000 美元）。