NIH Prior Approval Process Professional

NIH 事先批准流程专业人士

• 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
• 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

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.

项目摘要/摘要 科罗拉多州临床和转化科学研究所（CCTSI）提供了多种多样的 资源，教育和培训，人员，质量改进，监管支持以及 所有合作伙伴机构的教师和学员的资金机会。两个专业 父母UL1 NIH CTSA奖的目标是1）支持调查员开始翻译 以资助飞行员赠款项目的形式进行研究，2）支持初级调查员职业 通过CTSA KL2计划开发。两个CCTSI计划都涉及人类资助 受试者和脊椎​​动物的动物研究受到NIH延迟发作事先批准政策的影响。 本提案中要求的补充资金将支持经验丰富的努力 监管专业人员将致力于直接与调查人员合作进行准备和 向NCAT提交所需的事先批准文件以进行项目。与此 行政补充资金，CCTSI将招募并任命新的.75 FTE（9日历 QA/QA/QC NIH事先批准专业人员，具有人类受试者和动物的经验 研究法规以及对Cu-Anschutz机构政策和程序的熟悉， 以及ClinicalTrials.gov。和其他联邦政策。专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 个人将负责理解管理人类的监管环境 主题和脊椎动物的动物研究以及科学评估所需的文档 以及此类提出的研究的监管批准。 QA/QA NIH事先批准专业人员 将了解用于提交建议的NIH /NCATS流程和电子系统 审查和批准。该专业人员还将在我们的 关于NIH事先批准要求的机构。专门为 在科罗拉多州CTSA枢纽的NIH延迟发作的延迟发作之前 解决了NCAT在许多提交的建议中发现的缺点 批准：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；信息不足）； 3）材料的整体质量；和4） 遵守NIH和NCATS政策。该职位的成功实施将创建 系统的效率，降低总体错误并降低准备和审查的成本 申请。