CORE--PROTOCOL MANAGEMENT OFFICE

核心--协议管理办公室

• 批准号: 7310502
• 负责人: Robert C Young
• 金额: $ 19.72万
• 依托单位: FOX CHASE CANCER CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7310502
• 关键词: biomedical facility; clinical trials; data management; human data; neoplasm /cancer therapy; patient oriented research

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.

协议管理设施在激活和进行的各个层面参与 癌症治疗和预防试验，包括科学和技术审查，遵守 监管指南，患者注册和治疗，数据管理，向外部报告 赞助商，制备药代动力学和基因组样本，以及与主要研究人员和统计学家的持续沟通。 147名调查人员在上一个赠款期间利用了此设施，其中包括79个和同行评审的资金，共同代表了11个计划，这些计划涵盖了所有三个部门。在机构支持的情况下，在当前赠款周期中在六个关键领域实施了重大举措：1）数据和安全监控：实施我们的NCI批准的机构总体数据和安全监控计划。建立了一个L-LL协议监测委员会，以监督研究者发起的研究，而不需要完整的DSMB。 2）科学评论：研究审查委员会主席从设施主管（M. Bookman）过渡到独立研究员（G. Hudes）。为促进整体审查过程而建立的科学审查协调员角色。 3）质量保证：改进了资格标准的源文档和协议资格的100％内部审计。 4）监管支持：员工资源扩大以管理增加的研究量，修正案，安全报告，不良事件报告，HIPAA文档，赞助商通讯，证书，NCI-CTSU报告以及对知情同意文件的全球修订。 5）信息学：定制患者注册数据包的远程按需打印。生成所有方案化疗命令，包括药物递送的护理文献。修订自动报告以进行持续审查。用于管理安全报告的数据库工具。 6）集中研究操作：I期扩展 计划，包括协议支持实验室。建造新的17,000平方英尺 门诊护理临床研究馆。未来的举措包括支持I阶段计划的额外扩展，将化学疗法订单与机构信息系统的整合以及与NCI Cabig项目的协调。