CTSA Administrative Supplement QA/QC

布法罗翻译联盟(BTC)，其中包括布法罗大学(UB)健康科学 学校、我区主要医疗机构、四个重点研究机构和五个有影响力的社区 合作伙伴已着手制定全面的战略计划，为临床和医疗服务奠定坚实基础 翻译研究，以回应我们的社区需求。布法罗是纽约人口第二多的城市 纽约州，拥有丰富的文化历史。布法罗少数民族代表不足的比例(50%) 与美国2050年的预测相似，布法罗成为美国30年后面貌的一个缩影。 我们人口中有类似比例的人经历了健康差距。我们CTSA中心的愿景是实现 跨翻译领域的创新研究，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，需要具有广泛背景的人员的参与 一系列专业知识。临床和转化科学的复杂性以及国家监管环境 导致监管和研究管理专业知识的重要性与日俱增，以简化和加快 通过转化管道将发现转移到改善健康的方向。因此，有几项活动 由我们的CTSA支持，需要事先获得正式的NCATS批准。为以下项目提供清晰准确的文档 事先批准对于消除研究项目启动中的延误至关重要，从而绕过了一个重要的 推进翻译发现测试和实施的瓶颈。这个项目的总体目标是 补充是建立流程和程序以提供准确和高质量的数据和文件 向NCATS申请事先批准，以简化研究项目的启动和进行。对质量的支持 将参与管理向NCATS提供提交文件的流程的保证专家 并对本建议书要求提交的文件和材料进行质量审查。要完成 在这些目标中，我们提出了以下目标。我们将设立质量保证专员职位，以 为研究团队提供质量审查和专家协助，以准备与CTSA相关的 提交NCATS以供事先批准(目标1)。质量保证专家将与我们的 劳动力发展核心，为研究团队提供赠款管理方面的教育和培训， 监管事项和ct.gov提交，以确保遵守并减少实施的延误 研究项目(目标2)。最后，我们将监控我们中心流程的有效性，以提供准确、 向NCATS提交高质量的申请；遵守ct.gov；以及研究的教育和培训计划 团队(目标3)。在质量保证专家的支持下，这一新系统将显著提高质量 和我们向NCATS提交事先批准的及时性，简化研究的启动和进行 项目，并为我们中心的研究团队提供重要的教育和培训。

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.