NIH Prior Approval Process Professional

项目总结/文摘

PROJECT SUMMARY/ABSTRACT The Colorado Clinical and Translational Sciences Institute (CCTSI) provides a wide variety of resources, education and training, personnel, quality improvement, regulatory support and funding opportunities for faculty and trainees at all of the partner institutions. Two of the major objectives of the parent UL1 NIH CTSA award are to 1) support investigator initiated translational research in the form of funding pilot grant projects and to 2) support junior investigator career development through the CTSA KL2 program. Both CCTSI programs involve funding of human subject and vertebrate animal research subject to the NIH delay onset prior approval policy. Supplemental funds requested in this proposal will support the efforts of an experienced regulatory professional who will be dedicated to work directly with investigators to prepare and submit the required prior approval documentation to NCATS for their projects. With this administrative supplement funding, the CCTSI will recruit and appoint a new .75 FTE (9 calendar months) QA/QC NIH prior approval professional with experience in human subjects and animal research regulations and familiarity with CU-Anschutz institutional policies and procedures, as well as ClinicalTrials.gov. and other federal policies. The dedicated professional will have familiarity with the concepts of quality assurance, quality control, and process improvement. This individual will be responsible for understanding the regulatory environment governing human subject and vertebrate animal research and the documentation required for scientific evaluation and regulatory approval of such proposed research. The QA/QC NIH prior approval professional will understand the NIH /NCATS processes and electronic systems used to submit proposals for review and approval. This professional will also initiate improved training of researchers at our institution regarding NIH requirements for prior approval. Dedicating effort specifically to the management of the NIH delayed onset prior approval processes at the Colorado CTSA hub will address the shortcomings identified by NCATS in many of the proposals being submitted for approval: 1) Inaccurate/incomplete HSS fields; 2) Incomplete submissions (missing, inaccurate, or inconsistent documents; inadequate information); 3) Overall quality of the materials; and 4) Adherence to NIH and NCATS policies. Successful implementation of this position will create efficiencies in the system, reduce overall errors, and decrease the cost of preparing and reviewing applications.