Protocol Review

方案审查和监测系统提供了一个中央框架，与我们的机构审查委员会、监管机构和赞助商合作，每年对160多项新研究进行初步评估和优先排序，并对200多项临床研究进行持续监测。 在机构支助下，在本赠款周期内，在关键领域采取了重大举措： 1)数据和安全监测(DSM)：我们的机构总体DSM计划(DSM)已编写、审查、实施、NCI批准(2002年1月)，并进行了修订以供DCP-CCOP批准(2004年2月)。该计划包括建立一个当地的L-II阶段协议监测委员会(Burness，前身为R.Cohen)，为不需要完整或独立的协议监测委员会的研究人员发起的研究提供监督。 2)科学审查：研究审查委员会主席从仍担任审查人员的G·胡德夫妇过渡到独立调查员和委员会长期成员希尔德。 3)质量保证：随着调查人员发起计划在校外地点的发展，质量保证计划得到扩大。资格标准的持续来源文档和对方案资格的100%内部审核。 将扩展的质量保证程序与主dsmp集成。 4)监管支持：扩大人力资源，以管理增加的研究数量、修订、安全报告、不良事件报告、HIPAA文件、赞助商通信、认证、NCL-CTSU报告以及对知情同意文件的全球修订。5)信息学：增强的自动化报告，以支持持续审查。 专门的数据库工具，可有效管理和分发5000多份年度安全报告。

The Protocol Review and Monitoring System provides a centralized framework for initial evaluation and prioritization of more than 160 new studies per year and ongoing monitoring of more than 200 clinical research studies in collaboration with our Institutional Review Board, regulatory agencies, and sponsors. With institutional support, major initiatives were undertaken in key areas during the current grant cycle: 1) Data and Safety Monitonng (DSM): Our Institutional master DSM Plan (DSMP) was written, reviewed, implemented, NCI-approved (JAN-2002), and amended for DCP-CCOP approval (FEB-2004). The DSMP included creation of a local Phase l-ll Protocol Monitoring Committee (Burtness, formerly R. Cohen) to provide oversight for investigator-initiated studies that do not require a full or independent DSMB. 2) Scientific Review: Research Review Committee chair transitioned from the G. Hudes, who still serves as a reviewer, to Schilder, an independent investigator and long-term member of the committee. 3) Quality Assurance: Expansion of the QA program with growth of the Investigator Initiated Program at extramural sites. Continued source documentation for eligibility criteria and 100% internal auditing of protocol eligibility. Integration of expanded QA procedures with the master DSMP. 4) Regulatory Support: Staff resources expanded to manage increased study volume, amendments, safety reports, adverse event reports, HIPAA documentation, sponsor communications, certifications, NCl-CTSU reporting, and global revisions to informed consent documents. 5) Informatics: Enhanced automated reports to support continuing reviews. Specialized database tools for efficient management and distribution of more than 5000 annual safety reports.