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

NIH RePORTER · NIH · UL1 · $96,638 · view on reporter.nih.gov ↗

Abstract

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.

Key facts

NIH application ID
10251624
Project number
3UL1TR002373-04S3
Recipient
UNIVERSITY OF WISCONSIN-MADISON
Principal Investigator
ELIZABETH S BURNSIDE
Activity code
UL1
Funding institute
NIH
Fiscal year
2021
Award amount
$96,638
Award type
3
Project period
2020-12-15 → 2022-06-30