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州大学医学院（UMMS）研究办公室能够通过制定教育、培训和质量改进计划来提高人类受试者保护的能力。通过良好的临床实践（GCP）培训，网络增强和质量改进的内部检查，这些努力共同确定了未来对教育加强的需求。独立于未来的资金，UMMS完全致力于继续今年启动的所有教育和培训工作。然而，通过RFA OD-03-007提供额外一年的NIH支持，将使我们能够通过电子工具提高系统改进的能力，这是保持研究管理趋势的必要下一步。有助于更好地跟踪、管理和跟踪向机构审查委员会提交的材料的主要技术是一个称为Webridge的自动化网络系统。该自动化合规系统将促进IRB和委托人之间的合作 研究者通过电子提交新的方案申请，并通过自动化修订、不良事件和持续审查来确保依从性。本申请中详述的有助于增强人类受试者保护的其他技术是知情同意书的可读性软件程序和IRB的标准操作规程模板。包括一名培训协调员以促进这些努力的实施将是成功利用这些努力的关键。我们的临床系统合作伙伴UMass Memorial Health Care的两家附属医院将被纳入这些扩大的人类受试者保护工作。我们现有的人力资源和这些新技术的综合实力将使UMMS和我们的临床系统合作伙伴能够加强对人类受试者的保护，因为我们系统地监控我们的指标，以实现持续的质量改进。

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.