Web-Based Project Tracking to Enhance IRB Operations

拉什长老会-圣卢克医疗中心（RPSLMC）目前正在进行一系列精心策划的研究基础设施改进。目前正在进行的一项关键改进（由原始拨款#OD-02-003资助）是开发基于网络的项目跟踪系统，包括向IRB提交研究提案的电子提交;提案和相关文件的管理;研究者之间的沟通， IRB管理人员和IRB成员;跟踪IRB分配和审查;跟踪IRB批准和持续审查。该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用于其核心职责，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， 研究人员关于负责任的研究行为。我将为改善记录保存、促进IRB成员访问关键信息、防止IRB记录的暂时和永久丢失以及促进初始和持续审查的完整性提供关键步骤。该项目目前正处于最后的功能测试阶段，将于2003年9月1日成功完成。该提案概述了我们通过为项目跟踪系统增加额外功能（包括增强不良事件报告和跟踪）以及整合申办项目管理办公室和相关机构委员会批准（如 辐射安全委员会和生物安全委员会。同时，IRB管理部门将制定并实施针对研究者、研究管理人员和IRB成员的全面培训计划，以确保系统的平稳过渡，研究事务办公室将与芝加哥地区机构网络密切合作，以1）共享有关新技术、流程和培训计划的信息，2）协调并简化IRB提交，批准和现场监测时，涉及共同的协议。 参与该项目的所有关键人员都在Rush拥有丰富的研究管理经验，并积极参与了由Grant#OD-02-003资助的初始项目跟踪系统项目的成功开发。项目跟踪系统引入的效率规模以及本提案中概述的其他增强功能将使IRB成员、调查员和支持人员等在其核心工作中更加有效 我们的职责，并将提供适当水平的基础设施，以应对未来几年人类受试者研究数量的持续增长。

Rush-Presbyterian-St. Luke's Medical Center (RPSLMC) is currently in the midst of a series of orchestrated research infrastructure enhancements. One pivotal enhancement currently underway (and funded by the original Grant#OD-02-003) is the development of a web-based Project Tracking System that includes electronic submissions of research proposals to the IRB; management of proposals and related documents; communication among Investigators, IRB administrators, and IRB members; tracking of IRB assignment and review; and tracking of IRB approvals and continuing review. The scale of efficiencies introduced by this 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. I will provide a crucial step for improving record-keeping, facilitating IRB member access to critical information, safeguarding against temporary and permanent loss of IRB records, and facilitating the completeness of initial and continuing reviews. The project is currently in the final functionality testing phase and will be successfully completed by 9/1/03. This proposal outlines our plan for further strengthening the protection of human subjects at Rush by adding additional functions to the Project Tracking System, including enhanced adverse event reporting and tracking, and integrating Office of Sponsored Projects administration and related institutional committee approvals such as the Radiation Safety Committee and Biosafety Committee. Concurrently, a comprehensive training program for investigators, research administrators and IRB members will be developed and implemented by IRB administration to ensure a smooth transition of the system, and the Office of Research Affairs will work closely with a network of Chicago area institutions to 1) share information about the new technology, processes, and training programs, and 2) to coordinate and streamline IRB submission, approval and site monitoring when common protocols are involved. All of the key personnel involved on the project have extensive research administration experience at Rush and have been actively involved in the successful development of the initial Project Tracking System project funded by Grant#OD-02-003. The scale of efficiencies introduced by Project Tracking System, and additional enhancements outlined in this proposal will allow IRB members, investigators and support staff alike to be more effective at their core responsibilities, and will provide the appropriate level of infrastructure to handle the continued growth in the volume of human subjects research for years to come.