NIH Prior Approval Process Professional

项目摘要/摘要 科罗拉多州临床与转化科学研究所(CCTSI)提供了多种 资源、教育和培训、人事、质量改进、监管支持和 为所有合作机构的教职员工和实习生提供资金。其中两大专业 母公司UL1 NIH CTSA奖的目标是：1)支持研究人员发起的翻译 以资助试点项目和2)支持初级调查员职业生涯的形式进行研究 通过CTSA KL2计划进行开发。这两个CCTSI项目都涉及资助人类 受试者和脊椎动物研究受美国国立卫生研究院延迟起效事先批准政策的约束。 本提案中要求的补充资金将支持有经验的 监管专业人员，将致力于直接与调查人员合作，准备和 为他们的项目向NCATS提交所需的事先批准文件。有了这个 行政补充资金，CCTSI将招聘和任命一名新的0.75 FTE(9日历 几个月)NIH事先批准的QA/QC专业人员，具有人体和动物方面的经验 研究规定，熟悉CU-Anschutz机构政策和程序，如 以及ClinicalTrials.gov。和其他联邦政策。敬业的专业人士将拥有 熟悉质量保证、质量控制和过程改进的概念。这 个人将负责了解管理人类的法规环境 学科和脊椎动物研究以及科学评估所需的文件 以及监管机构对此类拟议研究的批准。NIH事先批准的QA/QC专业人员 将了解用于提交建议书的NIH/NCATS流程和电子系统 审查和批准。这位专业人员还将在我们的 关于NIH要求事先批准的机构。专门致力于 在科罗拉多州CTSA中心管理NIH延迟生效的事前审批程序将 解决NCATS在提交的许多提案中发现的缺陷 审批：1)不准确/不完整的HSS字段；2)不完整的提交(缺失、不准确、 或文件不一致；信息不充分)；3)材料的整体质量；以及4) 遵守NIH和NCATS政策。这一职位的成功实施将创造 提高系统效率，减少总体错误，并降低准备和审查的成本 申请。

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.