NIH Prior Approval Process Professional

NIH 事先批准流程专业人士

基本信息

批准号：
10158652
负责人：
RONALD J. SOKOL
金额：
$ 9.18万
依托单位：
UNIVERSITY OF COLORADO DENVER
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-05-01 至 2023-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10158652
关键词：
Address Adherence Administrative Supplement Animal Experimentation Award Calendar Clinical Investigator Clinical Research Clinical Sciences Clinical and Translational Science Awards Colorado Documentation Environment Faculty Familiarity Funding Funding Opportunities Goals Grant Health Hospitals Human Resources Human Subject Research Individual Institutes Institution Institutional Policy Measures Medical Medical center Modification Parents Pediatric Hospitals Policies Positioning Attribute Preparation Procedures Process Quality Control Regulation Research Research Personnel Research Training Resources Science Scientific Evaluation System Training Training and Education Translational Research United States National Institutes of Health Universities Vertebrates Veterans Work animal research subject base biobehavior career career development community based practice community organizations cost experience federal policy follower of religion Jewish health care service organization human subject improved interest investigator-initiated translational research practice-based research network programs quality assurance recruit response translational scientist translational study

项目摘要

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.

项目概要/摘要科罗拉多临床和转化科学研究所 (CCTSI) 提供多种资源、教育和培训、人员、质量改进、监管支持和为所有合作机构的教师和学员提供资助机会。其中两个主要父级 UL1 NIH CTSA 奖项的目标是 1) 支持研究者发起的转化研究以资助试点资助项目的形式进行研究，并 2) 支持初级研究员的职业生涯通过 CTSA KL2 计划进行开发。两个 CCTSI 计划都涉及人力资助受试者和脊椎动物研究须遵守 NIH 延迟发作事先批准政策。本提案中要求的补充资金将支持经验丰富的人的努力监管专业人员将致力于直接与调查人员合作，准备和向 NCATS 提交其项目所需的事先批准文件。有了这个行政补充资金后，CCTSI 将招募并任命一名新的 0.75 FTE（9 日历月） QA/QC NIH 事先批准的专业人员，具有人类受试者和动物方面的经验研究法规并熟悉 CU-Anschutz 机构政策和程序，例如以及 ClinicalTrials.gov。和其他联邦政策。敬业的专业人员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监管环境主题和脊椎动物研究以及科学评估所需的文件以及此类拟议研究的监管批准。 QA/QC NIH 事先批准专业人员将了解用于提交提案的 NIH /NCATS 流程和电子系统审查和批准。该专业人员还将启动对我们的研究人员的改进培训机构有关 NIH 要求的事先批准。专门致力于科罗拉多州 CTSA 中心的 NIH 延迟发作事先审批流程的管理将解决 NCATS 在提交的许多提案中发现的缺陷批准：1) HSS 字段不准确/不完整； 2) 提交的材料不完整（缺失、不准确、或文件不一致；信息不足）； 3）材料的综合质量；和 4) 遵守 NIH 和 NCATS 政策。该职位的成功实施将创造提高系统效率，减少总体错误，并降低准备和审核成本应用程序。