University of Wisconsin Institute for Clinical and Translational Research

7.项目概要/摘要： 尽管努力遵守NIH/NCATS法规，但威斯康星州大学（UW） 临床和转化研究（ICTR）在获得事先批准方面面临很大的失败率， KL 2和试点项目，无错误的eRA提交，XTrain文档和遵守其他 报告要求。此应用程序的目的是雇用，培训和定位质量 保证/质量控制（QA/QC）分析师将作为主要联系人， 加强事先批准程序，以支持向NCATS成功提交申请， 减少NCATS/NIH，UW-Madison PI，关键人员的行政负担， 行政人员。质量保证/质量控制分析员将是卢旺达问题国际法庭监管部门的主要联系人。 批准，将确定具体的过程问题，并实施干预措施来解决这些问题，并将 担任与UW健康科学机构审查委员会，UW研究和 赞助计划和NCATS QA联盟。成功的标准将包括满意 任职者完成质量保证/质量控制培训，建立标准操作程序， 减少了退回卢旺达问题国际法庭的错误数目，并缩短了监管部门成功批准的时间。的 质量保证/质量控制分析员的更广泛影响将是减少卢旺达问题国际法庭行政部门 纠正文件;减少NCATS/NIH工作人员寻求澄清的时间 和更正;解放卢旺达问题国际法庭的翻译研究人员，使其专注于其科学项目;并支持我们的 学术医疗中心实施严谨和创新的科学，以更有效地影响 患者和社区。

7. Project Summary/Abstract: Despite efforts to comply with NIH/NCATS regulations, the University of Wisconsin (UW) Institute for Clinical and Translational Research (ICTR) faces substantial failure rates in obtaining prior approval for KL2 and pilot projects, error-free eRA submissions, XTrain documentation and compliance with other reporting requirements. The objective of this application is to hire, train and position a Quality Assurance/Quality Control (QA/QC) Analyst to be the primary point of contact to streamline and strengthen prior approval processes to support successful submissions to NCATS, reducing the administrative burden on NCATS/NIH, UW-Madison PIs, key personnel, and administrative staff. The QA/QC Analyst will be the primary point of contact for ICTR regulatory approval, will define specific process problems and implement interventions to address them, and will serve as a primary liaison with the UW Health Sciences Institutional Review Board, UW Research and Sponsored Programs and the NCATS QA consortium. Metrics of success will include satisfactory completion of QA/QC training by incumbent, establishment of standard operation procedures (SOPs), reduced numbers of errors returned to ICTR, and reduced time for successful regulatory approval. The broader impacts of the QA/QC analyst will be to reduce the amount of time ICTR Administration spends correcting documentation; decrease the amount of NCATS/NIH staff time spent seeking clarification and corrections; free ICTR translational researchers to focus on their scientific projects; and support our academic medical center to implement rigorous and innovative science to more efficiently impact patients and communities.