CORE--PROTOCOL REVIEW AND MONITORING

核心——方案审查和监控

• 批准号: 7142540
• 负责人: Robert C Young
• 金额: $ 8.71万
• 依托单位: FOX CHASE CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-10 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7142540
• 关键词: behavioral /social science research tag; biomedical facility; clinical trials; data quality /integrity; health services research tag; human data; neoplasm /cancer therapy; patient oriented research; patient safety /medical error

The Protocol Management Facility participates at all levels in the activation and conduct of cancer treatment and prevention trials, including scientific and technical review, compliance with regulatory guidelines, patient registration and treatment, data management, reporting to outside sponsors, preparation of pharmacokinetic and genomic samples, and ongoing communication with principal investigators and statisticians. 147 investigators have utilized this facility during the last grant period, including 79 with peer-reviewed funding, together representing 11 Programs that span all three Divisions. With institutional support, major initiatives were undertaken in six key areas during the current grant cycle: 1) Data and Safety Monitoring: Implementation of our NCI-approved institutional master Data and Safety Monitoring Plan. A Phase l-ll Protocol Monitoring Committee was established for oversight of investigator-initiated studies not requiring a full DSMB. 2) Scientific Review: Research Review Committee chair transitioned from the Facility Director (M. Bookman) to an independent investigator (G. Hudes). Scientific Review Coordinator role established to facilitate overall review process. 3) Quality Assurance: Improved source documentation for eligibility criteria and 100% internal auditing of protocol eligibility. 4) Regulatory Support: Staff resources expanded to manage increased study volume, amendments, safety reports, adverse event reports, HIPAA documentation, sponsor communications, certifications, NCI-CTSU reporting, and global revisions to informed consent documents. 5) Informatics: Remote on-demand printing of customized patient registration packets. Generation of all protocol chemotherapy orders, including nursing documentation of drug delivery. Revision of automated reports for continuing review. Database tools for management of safety reports. 6) Centralized Research Operations: Expanded phase I program, including the protocol support laboratory. Construction of a new 17,000 square foot ambulatory care clinical research pavilion. Future initiatives include additional expansion to support the phase I program, integration of chemotherapy orders with institutional information systems, and coordination with NCI caBIG project.

礼宾管理机制在各级参与启动和执行 癌症治疗和预防试验，包括科学和技术审查，遵守 监管指南、患者登记和治疗、数据管理、对外报告 赞助商，药代动力学和基因组样本的制备，以及与主要研究人员和统计学家的持续沟通。147名调查人员在上一次拨款期间利用了这一设施，其中79人获得了同行审查的资金，总共代表了跨越所有三个部门的11个项目。在机构的支持下，在本赠款周期的六个关键领域采取了重大举措：1)数据和安全监测：执行我们的NCI批准的机构主数据和安全监测计划。建立了L二期方案监测委员会，以监督研究人员发起的研究，而不需要全面的dsmb。2)科学审查：研究审查委员会主席从设施主任(M·布克曼)过渡到独立调查员(G·胡德斯)。为促进全面审查进程而设立的科学审查协调员角色。3)质量保证：改进了资格标准的来源文件，并对方案资格进行了100%的内部审计。4)监管支持：扩大人力资源，以管理增加的研究数量、修正案、安全报告、不良事件报告、HIPAA文件、赞助者通信、认证、NCI-CTSU报告以及对知情同意文件的全球修订。5)信息学：远程按需打印定制的患者挂号包。生成所有方案化疗命令，包括药物输送的护理文件。自动报告的修订，以供继续审查。用于管理安全报告的数据库工具。6)集中研究业务：扩展第一阶段 计划，包括协议支持实验室。建造一个新的17,000平方英尺 门诊护理临床研究展馆。未来的举措包括进一步扩大以支持第一阶段计划，将化疗订单与机构信息系统整合，以及与NCI caBIG项目协调。