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，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

Transitioning from NRP to a combined PALS-NRP resuscitation model at a level IV NICU.

• DOI: 10.1038/s41372-022-01416-3
• 发表时间: 2022-11
• 期刊: JOURNAL OF PERINATOLOGY
• 影响因子: 2.9
• 作者: Harer, Matthew W.;Konkol, Laura J.;Limjoco, Jamie J.
• 通讯作者: Limjoco, Jamie J.

A Sociotechnical Systems Framework for the Application of Artificial Intelligence in Health Care Delivery.

• DOI: 10.1177/15553434221097357
• 发表时间: 2022-12
• 期刊: Journal of cognitive engineering and decision making
• 影响因子: 2

Sex hormones, body mass index, and related comorbidities associated with developing Sjögren's disease: a nested case-control study.

• DOI: 10.1007/s10067-022-06226-8
• 发表时间: 2022-10
• 期刊: Clinical rheumatology
• 影响因子: 3.4

Correlation Between Oral Health and Systemic Inflammation (COHESION): A Randomized Pilot Follow-Up Trial of a Plaque-Identifying Toothpaste.

• DOI: 10.1016/j.amjmed.2020.01.023
• 发表时间: 2020-08
• 期刊: The American journal of medicine
• 作者: Acharya A;Glurich I;Hetzel S;Kim K;Tattersall MC;DeMets DL;Hennekens CH
• 通讯作者: Hennekens CH

Temporal development of high-performance translational teams.

• DOI: 10.1017/cts.2023.545
• 发表时间: 2023
• 期刊: JOURNAL OF CLINICAL AND TRANSLATIONAL SCIENCE
• 影响因子: 2.6
• 作者: Brasier, Allan R.;Casey, Shannon L.;Resnik, Felice;Rolland, Betsy;Burnside, Elizabeth S.
• 通讯作者: Burnside, Elizabeth S.