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

威斯康星大学麦迪逊分校 CTSA 中心的专门质量保证/质量控制分析师

基本信息

批准号：
10251624
负责人：
ELIZABETH S BURNSIDE
金额：
$ 9.66万
依托单位：
UNIVERSITY OF WISCONSIN-MADISON
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-12-15 至 2022-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10251624
关键词：
Academic Medical Centers Address Administrative Supplement Attention Award Clinical Research Communities Complex Consumption Data Data Collection Documentation Ensure Evaluation Face Failure Goals Health Health Sciences Heart Human Resources Institutes Institutional Review Boards Intervention Mission Modification Outcome Patients Performance Pilot Projects Positioning Attribute Problem Solving Procedures Process Program Development Program Evaluation Progress Reports Protocols documentation Public Health Quality Control Regulation Reporting Research Research Personnel Science Standardization Structure Study Subject System Techniques Time TimeLine Training Translational Research United States National Institutes of Health Universities Update Wisconsin Work cohort design human subject improved innovation investigator training new technology operation programs quality assurance success symptom treatment 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. 项目总结/文摘: