Implementation of Data Safety Monitoring Plan (DSMP)

罗斯威尔公园癌症研究所（RPCi）是一个NCI指定的综合性癌症中心，在癌症病因学，预防和治疗方面进行广泛的临床前和临床研究。机构方案和科学诚信办公室（OIPSI）是RPCI办公室，负责监督确保人类受试者保护和根据科学实践和合规性的最高原则开展临床研究的过程，并支持研究所科学审查委员会（SRC）和机构审查委员会（IRB）。该办公室每年管理130多项新协议和425项修正案。最近在临床前和临床科学方面的招聘进展非常成功，我们估计在未来2-3年内临床研究活动将大幅增加，此外，RPCI致力于实施最现代和最完整的临床研究计划 管理可能。根据国家癌症研究所校外科学副主任办公室的指导方针，RPCI实施了数据安全监测计划。该计划为RPCI的人类受试者研究的开展和监督提供了一个全面的计划。本提案的目的是开发信息技术，以支持该计划的执行。该实施将分三个阶段进行：具体目标1：更新现有方案文件的自动化，以进行科学审查和1 RB批准，涵盖目前在合作项目或制药商发起的研究中积累的患者方案;具体目标2：实施具有自动合规性监测文件的稽查系统，以确保对批准研究中的受试者进行定期监测;具体目标3：建立符合FDA和HIPAA的内部网络系统， 不良事件报告（ADR），这将允许及时报告不良事件，并创建不良事件数据库，用于长期监测和不良事件的研究分析。这些具体目标的实现将提供系统增强，确保RPCI方案符合保护人类受试者和开展临床研究的最高标准和指南。

The Roswell Park Cancer Institute (RPCi) is an NCI-designated comprehensive cancer center which conducts extensive preclinical and clinical research in cancer etiology, prevention, and treatment. The Office of Institutional Protocols and Scientific Integrity (OIPSI) is the RPCI office responsible for oversight of processes that insure protection of human subjects and conduct of clinical research according to the highest principles of scientific practice and compliance and supports the Institute Scientific Review Committee (SRC) and the Institutional Review Board (IRB). This office manages more than 130 new protocols and 425 amendments each year. Recent recruitment in preclinical and clinical sciences are proceeding so successfully that we estimate a substantial increase in clinical research activity over the next 2-3 years, in addition, RPCI is committed to implementing the most modem and complete program in clinical research management possible. In accordance with the guidelines of the National Cancer Institute Office of Deputy Director for Extramural Science, RPCI has implemented a plan for Data Safety Monitoring. This plan provides a comprehensive scheme for conduct and oversight of human subjects research at RPCI. The objective of this proposal is to develop information technologies that support the implementation of this plan. This implementation will proceed in three phases: Specific Aim 1: update automation of existing documentation of protocols for scientific review and 1RB approval covering protocols currently accruing patients in co-operative programs or investigator-initiated studies; Specific Aim 2: implement the auditing system with automated compliance monitoring documentation to insure regular monitoring of subjects in approved studies; Specific Aim 3: establish an FDA and HIPAA compliant internal web-based system for adverse event reporting (ADR) that will allow for reat time reporting of adverse events and the creation of an adverse event database for the Iongterm monitoring and investigational profiling of adverse events. Implementation of these specific aims will provide system enhancements that will assure compliance of RPCI protocols with the highest standards and guidelines for protection of human subjects and conduct of clinical research.