PROJECT SUMMARY/ABSTRACT The Cincinnati Center for Clinical and Translational Science and Training (CCTST) provides investigators a menu of services. Most focus on direct support for investigators engaged in translational research including biostatistical and research design; biomedical informatics; participant interactions; ethics and regulatory support; workforce development; team science; acute care research; and community engagement. We provide a portfolio of pilot programs that allow entry level and established investigators to accrue preliminary data leading to success in obtaining extramural grants impacting the health of the community. Our pilot programs include Translational/Mentored Translational Pilot Grants; Just-in-Time Awards; Processes/Methods Grants; Community Health Grants; Clinical Research Feasibility Fund, and others. The parent UL1 NIH CTSA award focuses on 1) support of investigator initiated translational research and 2) support of junior investigator career development. These include funding of human subject and vertebrate animal research subject to the NIH delay onset prior approval policy. To support the pilot and KL2 programs, we are requesting supplemental funds supporting 2 staff comprising 1.0 FTE (12 calendar months), supported by institutional funding who will be dedicated to work directly with investigators to prepare and submit the required prior approval documentation to NCATS for their projects. These QA/QC NIH staff have experience with human subjects and vertebrate animal research regulations and familiarity with UC and Cincinnati Children’s Hospital policies and procedures and federal policies. The QA/QC NIH staff are familiar with the NIH /NCATS processes and electronic systems. They will be trained in quality assurance and control, and process improvement though CCTST Evaluation Core. Responsible for understanding the regulatory environment governing human subject and vertebrate animal research and documentation required. Through our Trans. Workforce Dev. Core, they will train researchers on NIH requirements for prior approval in the form of video tutorials in our CTROnline program. They have identified shortcomings that have slowed the process for investigators and will include narratives of how to facilitate the process of prior approval. Focusing on challenges identified by NCATS in proposals being submitted for approval: 1) Inaccurate/incomplete HSS fields; 2) Incomplete submissions; 3) Overall quality of materials; and 4) Adherence to NIH and NCATS policies. Creating dedicated staff for facilitating prior approval process will create efficiencies, reduce errors, and decrease time from approval of projects to implementation.

PROJECT NARRATIVE The NIH Delayed Onset Prior Approval Policies require investigators with pilot or KL2 award recipients to complete a variety of complicated documents for NIH review and approval which fulfill the federal regulations governing human subject and vertebrate animal research. The process is complicated and fraught with frequent modifications, which lead to errors and omissions as well as a substantial administrative burden on NIH and the CTSA Hubs. It commonly requires excessive time for the QA/QC staff, investigator and NIH staff to complete this process. This project will fund dedicated regulatory staff at the Center for Clinical and Translational Science and Training at the University of Cincinnati who will oversee all aspects of the local process and the process of submission to NCATS with goal to overcome barriers and inefficiencies and reduce the time from pilot grant or KL2 approval and the initiation of relevant studies.