Web-Based Project Tracking to Enhance IRB Operations

联邦政府资助的拉什-长老会圣。卢克医学中心（RPSLMC）在过去的十年里发展迅速，虽然RPSLMC在所有接受联邦研究经费的大学和学院中的相对排名上升得比其他所有机构都快，但研究管理基础设施并没有相应增长。经过一段时间的中心规划，RPSLMC正处于一系列精心安排的基础设施增强之中。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。提出的管理制度是至关重要的

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.