Adverse Events: Quantative Risk Assessment Tool

不良事件：定量风险评估工具

• 批准号: 6591976
• 负责人: MICHAEL. IAN PHILLIPS
• 金额: $ 10万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-09-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591976
• 关键词: Internet; computer program /software; computer system design /evaluation; disease /disorder proneness /risk; health related legal; health science research support; information systems; informed consent; mathematical model; therapy adverse effect

The goal of this project is to enhance and strengthen the human subjects protection program at the University of South Florida (USF) through the development and implementation of an electronic submission and tracking system for evaluating and coordinating adverse event (AE) reporting. Desirable outcomes include: o A Web-based electronic submission form will be created for the use of investigators to notify the Institutional Review Board (IRB) of an AE. o A database will be developed for capturing AE Report form contents directly from the Web-based submission form into an adverse events tracking database. o A statistical model will be created to correlate the information collected in the AE database with MedWatch reports and medical experts' ranking of adverse events' severity, such that a quantitative assessment of increases, decreases, or no changes in risk to human subjects participating in research. Information from the statistical model will be added to the AE Report and supporting documents for IRB assessment. o The resultant report will be made available via a secure Web site to the Authorized Institutional Official (Vice President for Research) and other appropriate university administrators, IRB Chair, board members, investigators, sponsors, and Data Safety and Monitoring Boards (DSMBs). By streamlining and quantifying key aspects of the qualitative AE assessment process, the IRB will be able to make rapid, reliable, real-time assessment of AEs. More importantly, the proposed enhancements will enable the IRB to take immediate action to protect human subjects from changes in research risks. USF will support the expansion of this project beyond AE Reporting to include other aspects of research compliance oversight such as new applications, continuing review, and changes in procedure. With these long-term objectives in mind, we have incorporated the most advanced, expandable server and programming software available on the market into this protocol. In addition, we will develop a training course to be used as a model for developing future continuing education programs for online submissions.

该项目的目标是通过开发和实施用于评估和协调不良事件（AE）报告的电子提交和跟踪系统来增强和加强南佛罗里达大学（USF）的人类受试者保护计划。理想的结果包括： o 将创建一个基于网络的电子提交表格，供调查人员通知 AE 的机构审查委员会 (IRB)。 o 将开发一个数据库，用于将 AE 报告表内容直接从基于 Web 的提交表捕获到不良事件跟踪数据库中。 o 将创建一个统计模型，将 AE 数据库中收集的信息与 MedWatch 报告和医学专家对不良事件严重程度的排名相关联，以便对参与受试者的风险增加、减少或无变化进行定量评估研究。统计模型的信息将添加到 AE 报告和 IRB 评估的支持文件中。 o 最终报告将通过安全网站提供给授权机构官员（负责研究的副校长）和其他适当的大学管理人员、IRB 主席、董事会成员、调查人员、赞助商以及数据安全和监控委员会 (DSMB)。 通过简化和量化定性 AE 评估流程的关​​键方面，IRB 将能够对 AE 进行快速、可靠、实时的评估。更重要的是，拟议的增强功能将使 IRB 能够立即采取行动，保护人类受试者免受研究风险变化的影响。 USF 将支持该项目扩展到 AE 报告之外，包括研究合规性监督的其他方面，例如新申请、持续审查和程序变更。考虑到这些长期目标，我们将市场上最先进、可扩展的服务器和编程软件纳入该协议中。此外，我们将开发一个培训课程，作为开发未来在线提交继续教育项目的模型。