Dedicated quality assurance/quality control analyst at UW-Madison CTSA Hub

7.项目摘要/摘要： 尽管努力遵守NIH/NCATS的规定，威斯康星大学(UW)研究所 临床和转化研究(卢旺达问题国际法庭)在获得事先批准方面面临着相当大的失败率。 KL2和试点项目、无错误的ERA提交、XTrain文档和遵守其他 报告要求。此应用程序的目标是招聘、培训和定位有质量的人 保证/质量控制(QA/QC)分析师将成为简化和 加强以前的审批程序，以支持成功提交NCATS， 减轻NCATS/NIH、UW-Madison PI、关键人员和 行政人员。QA/QC分析员将是卢旺达问题国际法庭监管的主要联系人。 批准，将定义具体的流程问题并实施干预措施来解决这些问题，并将 作为与威斯康星州健康科学机构审查委员会、威斯康星州研究和 赞助项目和NCATS QA联盟。衡量成功的标准将包括满意度 由在职人员完成QA/QC培训，建立标准操作程序(SOP)； 减少了返回卢旺达问题国际法庭的错误数量，并减少了成功获得监管批准的时间。这个 QA/QC分析员的更广泛影响将是减少卢旺达问题国际法庭行政当局花费的时间 更正文档；减少NCATS/NIH工作人员寻求澄清所花费的时间 和纠正；解放卢旺达问题国际法庭的翻译研究人员，让他们专注于他们的科学项目；并支持我们的 学术医学中心将实施严谨和创新的科学，以更有效地影响 病人和社区。

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.