The integrated Translational Health Research Institute of Virginia (iTHRIV): Using Data to Improve Health

摘要 临床转化科学奖的新人类受试者研究事先批准提交流程 hubs已于2019年初实施。新的eRA人类受试者系统（HSS）的激活提供了 有机会整合和简化事先批准的提交、审查和批准流程 涉及人类受试者研究的请求。尽管HSS系统为团队提供了一种集中的方法， 提交，它确实在NIH审查层面带来了新的挑战。为了改善我们的流程， 美国国立卫生研究院（NIH）的研究人员和评审人员， 弗吉尼亚州（iTHRIV）是弗吉尼亚联邦公共和私营机构的合作项目， 提议增设一个专门的质量保证/质量控制职位。新的iTHRIV研究 质量经理将对向NCATS提交的CTSA相关资料、向eRA提交的资料进行质量审查 人类受试者系统，并管理整个事先批准过程。培训iTHRIV员工， 人类受试者提交的质量和监管最佳实践是我们计划的另一个目标， 扩展到包括我们的合作伙伴网站，以及与广泛的CTSA国家网络共享。研究 质量经理将协调iTHRIV合作伙伴的质量措施和流程，包括 将最佳做法纳入所有NCATS提交工作（目标1），制定和传播培训方案， 人类受试者研究提交流程（目标2），并积极参与国家工作组 在CTSA网络中分享见解和最佳实践（目标3）。增加研究质量 经理将提供培训计划，以满足我们的研究社区的关键教育需求， 发展我们劳动力的技能和知识，使iTHRIV能够实现其劳动力的主要目标 开发、协作和整合、方法和流程，并允许通过iTHRIV进行精简 共享资源

ABSTRACT A new Human Subject Research prior approval submission process for Clinical Translational Science Award hubs was implemented in early 2019. The activation of the new eRA Human Subjects System (HSS) provided an opportunity to consolidate and simplify the submission, review and approval process for Prior Approval requests involving human subjects research. Although, the HSS system afforded teams a centralized method for submission, it did create new challenges at the NIH review level. In order to improve the process for our researchers as well as the reviewers at the NIH, the integrated Translational Health Research Institute of Virginia (iTHRIV), a collaboration of public and private institutions across the Commonwealth of Virginia, proposes the addition of a dedicated quality assurance/ quality control position. The new iTHRIV Research Quality Manager will perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System, and manage the overall prior approval process. Training the iTHRIV workforce in quality and regulatory best practices of human subject submissions is another objective which we plan to extend to include our partner sites, as well as share with the broad CTSA national network. The Research Quality Manager will harmonize quality measures and processes across the iTHRIV partners including incorporating best practices for all NCATS submission (Aim1), develop and disseminate training programs for human subject research submission processes (Aim 2) and actively participate in the national working groups sharing insights and best practices across the CTSA network (Aim 3). The addition of a Research Quality Manager will provide training programs to fill a key educational need of our research community to further develop the skills and knowledge of our workforce and enable iTHRIV to meet its primary aims of workforce development, collaboration and integration, methods and processes and allow streamlining through the iTHRIV Commons.