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.
3 sentences Conducting high quality, safe and compliant research is a mission of the UW ICTR CTSA hub. A dedicated quality assurance/quality control position will develop processes and procedures to efficiently, accurately, and consistently provide project related information to the NIH and NCATS. The proposed project is relevant to public health because it will shorten the timeline for regulatory approval, enabling our program to develop important health interventions.
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