Implementation of Data Safety Monitoring Plan (DSMP)

罗斯威尔公园癌症研究所(RPCI)是NCI指定的综合性癌症中心，在癌症病因、预防和治疗方面进行广泛的临床前和临床研究。机构规程和科学诚信办公室(OIPSI)是机构方案和科学诚信办公室，负责监督确保保护人体受试者的过程，并根据科学实践和合规的最高原则进行临床研究，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。最近临床前和临床科学领域的招聘进展非常顺利，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致力于实施临床研究中最现代化和最完整的计划。 管理是可能的。根据国家癌症研究所办公室外科学副主任的指导方针，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进行和监督提供了一个全面的方案。这项提议的目标是开发支持执行这项计划的信息技术。这项实施将分三个阶段进行：具体目标1：更新现有的科学审查方案文件和1RB批准方案，涵盖目前在合作方案或研究人员发起的研究中积累患者的方案；具体目标2：实施具有自动遵从性监测文件的审计系统，以确保对已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，用于 不良事件报告(ADR)，允许实时报告不良事件，并创建不良事件数据库，用于不良事件的长期监测和调查性描述。这些具体目标的实施将提供系统改进，确保RPCI协议符合保护人体受试者和进行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.