CTSA Administrative Supplement QA/QC

CTSA 行政补充 QA/QC

• 批准号: 10382581
• 负责人: Timothy F Murphy
• 金额: $ 9.46万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10382581
• 关键词: Administrative Supplement; Award; Buffaloes; Bypass; Censuses; Cities; Climate; Clinical Research; Clinical Sciences; Communities; Complex; Data; Documentation; Effectiveness; Ensure; Environment; Foundations; Funding; Future; Goals; Grant; Growth; Health; Health Sciences; Healthcare; Human Resources; Influentials; Institutes; Institution; Interdisciplinary Study; Monitor; New York; Pilot Projects; Population; Positioning Attribute; Procedures; Process; Recording of previous events; Research; Research Institute; Research Project Grants; Schools; Specialist; Strategic Planning; Support System; Testing; Time; Training Programs; Training and Education; Translational Research; Underrepresented Minority; Universities; Vision; Work; Workforce Development; base; experience; health disparity; improved; innovation; novel strategies; quality assurance; response; translational pipeline; translational study

The Buffalo Translational Consortium (BTC), which includes the University at Buffalo (UB) health sciences schools, the major healthcare institutions in our region, four key research institutes and five influential community partners, have embarked on a comprehensive strategic plan to build a strong foundation for clinical and translational research in response to our community needs. Buffalo is the second most populous city in New York State and has a rich cultural history. The proportion of underrepresented minorities in Buffalo (50%) parallels that projected for the US in 2050, making Buffalo a microcosm of what the US will look like in 30 years. A similar proportion of our population experiences health disparities. The vision for our CTSA hub is to perform innovative research across the translational spectrum to improve the health of our community and the nation. Achieving these ambitious goals is a complex process that requires the participation of personnel with a wide range of expertise. The complexity of clinical and translational science and the national regulatory climate have led to an increasing importance of regulatory and research administrative expertise to streamline and accelerate moving discoveries through the translational pipeline toward improving health. As a result, several activities supported by our CTSA require formal NCATS prior approval. Providing clear and accurate documentation for prior approval is critical in eliminating delays in the start-up of research projects, thus bypassing an important bottleneck in advancing the testing and implementation of translational discoveries. The overall goal of this Supplement is to establish processes and procedures to provide accurate and high quality data and documents to NCATS for prior approval to streamline the start-up and conduct of research projects. Support for a Quality Assurance Specialist who will participate in the management of the process of providing submissions to NCATS and perform quality reviews of documents and material submitted is requested in this proposal. To accomplish these goals, we propose the following Aims. We will establish a Quality Assurance Specialist position to provide quality reviews and expert assistance to research teams in preparing CTSA-related submissions to NCATS for prior approval (Aim 1). The Quality Assurance Specialist will work with our Workforce Development Core to provide education and training to research teams in grants management, regulatory matters and CT.gov submissions to ensure compliance and reduce delays in implementation of research projects (Aim 2). Finally, we will monitor the effectiveness of our hub processes in providing accurate, high quality submissions to NCATS; CT.gov compliance; and education and training programs for research teams (Aim 3). This new system supported by a Quality Assurance Specialist will substantially improve the quality and timeliness of our submissions to NCATS for prior approvals, streamline the start-up and conduct of research projects, and provide important education and training to research teams in our hub.

布法罗转化联盟（BTC），其中包括布法罗大学（UB）健康科学大学 学校，我们地区的主要医疗机构，四家主要的研究机构和五个有影响力的社区 合作伙伴已经制定了一项全面的战略计划，为临床和 响应我们社区需求的翻译研究。布法罗是新的第二大城市 约克州，有着丰富的文化历史。布法罗中代表性不足的少数族裔比例（50％） 在2050年向美国预计的相似之处，使布法罗成为30年来美国看起来的缩影。 我们的人口中有类似的比例经历健康差异。我们CTSA枢纽的愿景是执行 在翻译范围内的创新研究，以改善我们社区和国家的健康。 实现这些雄心勃勃的目标是一个复杂的过程，需要参与 专业知识范围。临床和转化科学以及国家监管气候的复杂性已有 导致监管和研究行政专业知识越来越重要，以简化和加速 通过转化管道将发现转移到改善健康状况。结果，几项活动 由我们的CTSA支持，需要事先批准正式的NCAT。提供清晰准确的文档 事先批准对于消除研究项目启动的延迟至关重要，从而绕过一个重要的 瓶颈在进行转化发现的测试和实施方面。总体目标 补充是建立流程和程序，以提供准确，高质量的数据和文件 向NCATS事先批准，以简化研究项目的启动和进行。支持质量 保证专家将参与向NCAT提供意见书的过程管理 并在此提案中要求对提交的文件和材料进行质量审查。完成 这些目标，我们提出以下目标。我们将建立质量保证专家职位 为研究团队提供质量评论和专家帮助，以准备与CTSA相关的 提交给NCAT的事先批准（AIM 1）。质量保证专家将与我们合作 劳动力发展核心，为赠款管理的研究团队提供教育和培训， 监管事项和CT.GOV提交，以确保合规性并减少实施的延迟 研究项目（目标2）。最后，我们将监控枢纽过程在提供准确的， 向NCAT提出的高质量提交； CT.GOV合规性；以及研究教育和培训计划 团队（目标3）。这个由质量保证专家支持的新系统将大大提高质量 我们向NCAT提交的及时性进行事先批准，简化研究的启动和进行 项目，并向我们的枢纽中的研究团队提供重要的教育和培训。