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University of Wisconsin Institute for Clinical and Translational Research

威斯康星大学临床与转化研究所

基本信息

批准号：
10701360
负责人：
ELIZABETH S BURNSIDE
金额：
$ 11.47万
依托单位：
UNIVERSITY OF WISCONSIN-MADISON
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-12-05 至 2027-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10701360
关键词：
Academic Medical Centers Address Administrative Supplement Attention Award Clinical Research Communities Complex Consumption Data Data Collection Dedications Documentation Ensure Evaluation Face Failure Goals Health Health Sciences Heart Human Resources IACUC Institutional Review Boards Intervention Mission National Center for Advancing Translational Sciences Outcome Patients Performance Pilot Projects Positioning Attribute Problem Solving Procedures Process Program Development Program Evaluation Progress Reports Public Health Quality Control Regulation Reporting Research Research Personnel Science Standardization Structure Study Subject System Techniques Time Training Translational Research United States National Institutes of Health Universities Update Wisconsin Work cohort design experience human subject improved innovation investigator training new technology operation process improvement programs quality assurance success symptom treatment timeline translational scientist

项目摘要

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.

7. 项目概要/摘要：尽管努力遵守 NIH/NCATS 法规，威斯康星大学 (UW) 研究所临床和转化研究 (ICTR) 在获得事先批准方面面临着巨大的失败率 KL2 和试点项目、无错误的 eRA 提交、XTrain 文档以及其他合规性报告要求。该应用程序的目的是雇用、培训和定位优质人才保证/质量控制 (QA/QC) 分析师将成为简化和维护流程的主要联系人加强事先审批流程，以支持向 NCATS 成功提交，减轻 NCATS/NIH、威斯康辛大学麦迪逊分校 PI、关键人员和行政人员。 QA/QC 分析师将成为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，并将担任与华盛顿大学健康科学机构审查委员会、华盛顿大学研究和赞助计划和 NCATS QA 联盟。成功的衡量标准将包括令人满意的任职者完成质量保证/质量控制培训，建立标准操作程序（SOP），减少返回卢旺达问题国际法庭的错误数量，并缩短成功监管审批的时间。这质量保证/质量控制分析师的更广泛影响将是减少卢旺达问题国际法庭行政部门花费的时间更正文件；减少 NCATS/NIH 工作人员寻求澄清所花费的时间和更正；让卢旺达问题国际法庭的转化研究人员能够专注于他们的科学项目；并支持我们的学术医疗中心实施严谨和创新的科学，以更有效地产生影响患者和社区。

项目成果

期刊论文数量（495）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Prenatal care experiences among pregnant women with obesity in Wisconsin, United States: a qualitative quality improvement assessment.

DOI：
10.1186/s12884-021-03629-4
发表时间：
2021-02-15
期刊：
BMC pregnancy and childbirth
影响因子：
3.1
作者：
Hurst DJ;Schmuhl NB;Voils CI;Antony KM
通讯作者：
Antony KM

A Sociotechnical Systems Approach Toward Tailored Design for Personal Health Information Management.

针对个人健康信息管理量身定制设计的社会技术系统方法。

DOI：
10.35680/2372-0247.1411
发表时间：
2020
期刊：
Patient experience journal
影响因子：
0
作者：
Werner NE;Tong M;Nathan-Roberts D;Arnott-Smith C;Tredinnick R;Ponto K;Melles M;Hoonakker P
通讯作者：
Hoonakker P

After the Randomized Trial: Implementation of Community-Based Continence Promotion in the Real World.

在随机试验之后：在现实世界中实施基于社区的延续性促进。