Protocol Review

方案审查和监测系统提供了一个集中的框架，用于每年对160多项新研究进行初步评估和优先排序，并与我们的机构审查委员会、监管机构和申办者合作，对200多项临床研究进行持续监测。 在机构支持下，在本赠款周期内在关键领域采取了重大举措： 1)数据和安全性审查（DSM）：我们的机构DSM主计划（DSMP）已编写、审查、实施、NCI批准（2002年1月），并修订为DCP-CCOP批准（2004年2月）。DSMP包括建立一个当地的I-II期方案监测委员会（Burtness，以前的R。Cohen）对不需要完整或独立DSMB的制药商发起的研究进行监督。 2)科学审查：研究审查委员会主席从G。Hudes仍然担任审查员，Schilder是独立调查员和委员会的长期成员。 3)质量保证：随着校外研究中心研究者发起的项目的增长，QA项目得到扩展。合格性标准的持续源文件和方案合格性的100%内部稽查。 扩展QA程序与主DSMP的集成。 4)监管支持：扩大了工作人员资源，以管理增加的研究量、修正案、安全性报告、不良事件报告、HIPAA文件、申办者通信、认证、NCl-CTSU报告和知情同意文件的全球修订。5)信息学：增强的自动报告，以支持持续审查。 专业的数据库工具，用于有效管理和分发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.