Quality Improvement through Electronic Enhancements

美国国立卫生研究院通过RFA OD-02-003提供的支持，使马萨诸塞大学医学院研究办公室能够通过发展教育、培训和质量改进举措，加强保护人类受试者的能力。通过良好临床规范（GCP）培训、网络改进和内部质量改进检查，这些努力共同确定了未来加强教育的需要。独立于未来的资金，UMMS完全致力于继续所有的教育和培训工作，已经启动了今年。然而，通过RFA OD-03-007获得NIH额外一年的支持，将使我们能够通过电子工具增强系统改进的能力，这是跟上研究管理趋势的必要下一步。在能够更好地跟踪、管理和跟进提交给机构审查委员会的材料的技术中，最主要的是一个被称为Webridge的基于网络的自动化系统。这个自动化的合规系统将促进内部审查委员会和委托人之间的协作

The support of the National Institutes of Health through RFA OD-02-003 allowed the Office of Research at University of Massachusetts Medical School (UMMS) to enhance the capacity for human subjects protection through the development of education, training and quality improvement initiatives. Through Good Clinical Practice (GCP) training, web enhancements and internal inspections for quality improvement, these efforts have collectively identified future needs for educational reinforcements. Independent of future funding, the UMMS is fully committed to the continuation of all the education and training efforts that have been initiated this year. The availability of an additional year of NIH support through RFA OD-03-007, however, will allow us to enhance our capacity for system improvements through electronic tools, a necessary next step to keep current with trends in research administration. Primary among the technology that could facilitate better tracking, management and follow-up of submissions to the Institutional Review Board is an automated web-based system known as Webridge. This automated compliance system would facilitate collaboration between the IRB and principal investigators through electronic submission of new protocol applications and ensure compliance by automating amendments, adverse events and continuing reviews. Other technology detailed in this application to assist in enhancement of human subjects protections are readability software programs for consent documents and Standard Operating Procedure templates for the IRB. The inclusion of a training coordinator to facilitate the implementation of these efforts will be key to their successful utilization. Two of the affiliate hospitals to our clinical system partner, UMass Memorial Health Care, will be included in these expanded efforts for human subjects protections. The combined strength of our existing human resources and these new technologies will allow UMMS and our clinical system partners to enhance human subjects protections as we monitor our metrics systematically for continuous quality improvement.