Web-Based Project Tracking to Enhance IRB Operations

基于网络的项目跟踪增强 IRB 运营

• 批准号: 6591589
• 负责人: HENRY R BLACK
• 金额: $ 15万
• 依托单位: RUSH UNIVERSITY MEDICAL CENTER
• 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 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591589
• 关键词: Internet; computer program /software; computer system design /evaluation; computer system hardware; health science research support; information retrieval; information systems; university

While federally-funded research activity at Rush-Presbyterian-St. Luke's Medical Center (RPSLMC) has grown dramatically over the last ten-year period, and while the relative ranking of RPSLMC among all universities and colleges receiving federal research funding has climbed more quickty than that for all but a few other institutions, the research administration infrastructure has not grown proportionally. After a period of central ptanning, RPSLMC is in the midst of a series of orchestrated infrastructure enhancements. One of the most pivotal research administration enhancements planned is the development and implementation of a new electronic management system for IRB administration. The proposed management system is a critical step for improving record-keeping, facilitating IRB member access to cdtical information, safeguarding against temporary or permanent loss of IRB records, and facilitating the completeness of initial and continuing reviews. With this project, RPSLMC proposes to work within an experienced software product company to develop a web-based Project Tracking System that would allow submissions of research proposals to the institutional IRB; management of proposals and related documents; communication among Investigators, IRB administrators, and IRB members; tracking of IRB assignment and review; tracking of IRB approval and continuing review; and archiving of all IRB-related documents and records. The contractor will undertake and complete all software development and implementation work described within 12 months, subject to validation and acceptance of the product by RPSLMC after a scheduled "Quality Assurance Test Solution" stage at the end of the development period. The budget covers the cost of developing and implementing the software product, travel for the PI and co-PI as specified by the RFA, and a token amount of time/effort for one key staffperson. The remaining costs -- for necessary hardware, and most of the time and effort for key RPSLMC staff involved -- will be borne by RPSLMC. The scale of efficiencies introduced by the proposed software system will allow IRB members and support staff alike to devote a significantly greater portion of their time to their core responsibilities -- i.e., evaluating proposals for safety, risk, and safeguards; improving the quality of the informed consent process; and educating investigators and research staff about the responsible conduct of research.

虽然联邦资助的研究活动在拉什长老会-圣卢克医学中心（RPSLMC）在过去十年期间急剧增长，而RPSLMC在所有大学和学院之间的相对排名接受联邦研究资金已经攀升更快，但所有其他机构，研究管理基础设施并没有按比例增长。经过一段时间的集中规划，RPSLMC正在进行一系列精心策划的基础设施增强。计划中最关键的研究管理改进之一是为IRB管理开发和实施新的电子管理系统。拟议的管理系统是一个关键的 改善记录保存、促进IRB成员访问临床信息、防止IRB记录暂时或永久丢失以及促进初始和持续审查的完整性的步骤。 通过该项目，RPSLMC建议与一家经验丰富的软件产品公司合作，开发一个基于网络的项目跟踪系统，该系统将允许向机构IRB提交研究提案;管理提案和相关文件;研究者、IRB管理员和IRB成员之间的沟通;跟踪IRB分配和审查;跟踪IRB批准和持续审查;所有IRB相关文件和记录的存档。承包商将在12个月内承担并完成所有软件开发和实施工作，并在预定的“质量保证测试解决方案”后由RPSLMC对产品进行验证和验收。 发展期结束时的阶段。预算包括开发和实施软件产品的成本、RFA规定的PI和co-PI的差旅费以及一名关键工作人员的象征性时间/工作量。其余的费用-必要的硬件费用，以及所涉的RPSLMC主要工作人员的大部分时间和精力-将由RPSLMC承担。拟议的软件系统所带来的效率规模将使IRB成员和支持人员能够将更多的时间投入到他们的核心职责上，即，评估安全性、风险和保障措施的建议;提高知情同意过程的质量;教育研究人员和研究人员负责任地开展研究。