Proposal for Dedicated QAQC Personnel to Promote Consistency and Efficiency of CTSA-related Submissions

项目总结/文摘

PROJECT SUMMARY/ABSTRACT This Administrative Supplement describes a staff position to provide detailed regulatory assistance to the UC Davis Clinical and Translational Science Center (CTSC). Specifically, this new position will assist the CTSC with the preparation and tracking of applications for delayed onset human subjects' research. When funded by the National Institutes of Health (NIH) National Center for Advancing Translational Science (NCATS), human subjects' research requires review and approval by the agency before grant-funded projects can begin. This prior approval process is common with Pilot Awards and KL2 projects funded by the Clinical and Translational Science Award (CTSA) grant. The development of applications that require Prior Approval necessitate the collection, assembly, organization, and submission of key information into a federal system. To ensure these applications are complete, accurate, and ready for review is a complex and time-consuming task. In addition, the NIH requires that publications resulting from federally funded research comply with the Public Access Policy. This ongoing process requires the identification of applicable publications that meet the criteria, determination of the appropriate compliance pathway, and facilitation of compliance for the annual report. These steps are not always straightforward to authors and often take significant effort on the part of the parent award recipient that provides the federal funding. The detailed nature of this work aligns well with the skills required to manage Prior Approval applications. Both responsibilities are essential to a successful CTSA, and if not performed efficiently and consistently, there is great potential of wasted time on the part of NCATS staff and consequent delays in the commencement of research and receipt of annual funding. The individual hired to assume these responsibilities will be embedded within the CTSC, trained on and familiar with the institutional and federal systems, and will play a key role with the CTSC Translational Research Compliance Committee. The requisite skills and responsibilities will yield well integrated, fully prepared, and highly compliant applications and reports to NCATS. This dedicated individual will also be able to participate in NCATS Quality Assurance and Quality Control meetings to help disseminate skills and tools developed to facilitate these processes. To facilitate the consistent and efficient submission of complete, accurate CTSA-related information to NCATS, the UC Davis CTSC proposes to hire and deploy a highly qualified person with the requisite skills and subject matter expertise to: 1) improve consistency of applications for prior approval; 2) develop systems to streamline collection and review of required compliance reports; and 3) manage and disseminate quality improvement tools to foster compliance with grant reporting.