University of Wisconsin Institute for Clinical and Translational Research

威斯康星大学临床与转化研究所

• 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
• 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

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，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。

项目成果

Convergent brain microstructure across multiple genetic models of schizophrenia and autism spectrum disorder: A feasibility study.

• DOI: 10.1016/j.mri.2020.04.002
• 发表时间: 2020-07
• 期刊: Magnetic resonance imaging
• 影响因子: 2.5
• 作者: Barnett BR;Casey CP;Torres-Velázquez M;Rowley PA;Yu JJ
• 通讯作者: Yu JJ

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
• 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。

• DOI: 10.1111/jgs.16771
• 发表时间: 2020-11
• 期刊: Journal of the American Geriatrics Society
• 影响因子: 6.3
• 作者: Schmuhl NB;Brow KA;Wise ME;Myers S;Mahoney JE;Brown HW
• 通讯作者: Brown HW

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

Task Analysis of In-Home SARS-CoV-2 Rapid Antigen Testing by Families.

• DOI: 10.1542/peds.2022-056681
• 发表时间: 2022-08-01
• 期刊: PEDIATRICS
• 影响因子: 8
• 作者: Barton, Hanna J.;Werner, Nicole E.;Morgen, Makenzie;DeMuri, Gregory P.;Kelly, Michelle M.;Wald, Ellen R.;Warner, Gemma;Katz, Barbara;Coller, Ryan J.
• 通讯作者: Coller, Ryan J.