CORE--PROTOCOL SPECIFIC RESEARCH

礼宾管理设施在各级参与启动和开展 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 申办者，药代动力学和基因组样本的制备，以及与主要研究者和统计学家的持续沟通。在上一个赠款期间，147名研究人员利用了该设施，其中79名研究人员获得了同行评审的资金，共同代表了跨越所有三个部门的11个项目。在机构的支持下，在本赠款周期内，在六个关键领域采取了重大举措：1）数据和安全监测：实施我们的NCI批准的机构主数据和安全监测计划。成立了I-II期方案监查委员会，以监督不需要完整DSMB的制药商发起的研究。2)科学审查：研究审查委员会主席从设施主任（M。Bookman）向独立调查员（G。Hudes）。确立科学审查协调员角色，以促进总体审查过程。3)质量保证：改进了合格性标准的源文件，并对方案合格性进行了100%的内部稽查。4)监管支持：扩大了工作人员资源，以管理增加的研究量、修订、安全性报告、不良事件报告、HIPAA文件、申办者通信、认证、NCI-CTSU报告和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登记包。生成所有方案化疗订单，包括药物输送的护理文件。修订自动化报告，供持续审查。用于管理安全报告的数据库工具。6)集中研究运营：扩展阶段I 包括协议支持实验室。新建17,000平方英尺 门诊护理临床研究馆。未来的计划包括进一步扩展以支持I期计划，将化疗订单与机构信息系统整合，以及与NCI caBIG项目协调。

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.