Core-004

研究方法部分由两个部分组成，重点是规划、实施和 在OHSU和合作机构实施高质量的临床和转化研究(CTR)： 生物统计学、流行病学和研究设计(BERD)以及监管知识和支持(RKS)。在……里面 OCTRI 2.0，每个组成部分都有明确的目标，并伴随着相关的具体目标 实现这些目标。所有研究方法的目标都与OCTRI的总体目标很好地一致； 将衡量和评价每个单元对实现这些目标的贡献。两者都有 各构成部分利用OCTRI以往供资周期取得的成就，并利用下列活动 对OHSU基础设施(特别是生物统计和设计计划)至关重要的成功单位 [BDP]和临床研究办公室)，以确保高效和及时地实现目标。 近年来，应对CTR挑战取得了长足的进步；然而，对复杂结构的研究 系统需要创新的方法和流程来有效和高效地将发现转化为 转变为改善健康的干预措施。反恐审查的成功离不开下列方面的考虑 研究伦理、研究设计、数据分析和解释。因此，专门用于规划的核心， 在OHSU实施高质量的CTR是实现总体目标的关键 OCTRI 2.0的目标。应对国际移民组织报告中提出的推动CTR创新的挑战， OCTRI的生物统计学、流行病学和研究设计部分(OCTRI-BERD)提出了倡议 旨在促进方法发展，提供灵活的个性化培训体验，以及 促进BERD从业者的专业发展。此外，OCTRI-BERD将进一步增强 通过我们的生物统计大学共享提供协作和咨询服务 资源、生物统计与设计课程。监管知识和支持部分建议 旨在提供监管咨询服务的举措，培训工作人员 保护，并缓解CTR中与监管相关的瓶颈。这些努力将推动八达通社的任务 并在区域和整个CTSA网络中催化CTR。

The Research Methods section comprises two components focused on planning, operationalizing, and implementing high quality Clinical and Translational Research (CTR) at OHSU and partnering institutions: Biostatistics, Epidemiology and Research Design (BERD), and Regulatory Knowledge and support (RKS). In OCTRI 2.0, each of these components has well-articulated goals, accompanied by relevant specific aims to accomplish those goals. All the Research Methods aims are well aligned with the overarching aims for OCTRI; contributions for each of the modules toward achievement of those aims will be measured and evaluated. Both components capitalize on achievements in the prior OCTRI funding cycles, and leverage activities of successful units that are essential to the OHSU infrastructure (in particular the Biostatistics & Design Program [BDP] and the Office of Clinical Research), to ensure efficient and timely progress toward goals. In recent years, great strides have been made tackling CTR challenges; however, the studies of complex systems requires innovative methodologies and processes to effectively and efficiently translate discoveries into interventions to improve health. Indispensable to the success of CTR are considerations in the areas of research ethics, study design, data analyses, and interpretation. Thus, Cores dedicated to planning, operationalizing, and implementing high quality CTR at OHSU are essential for achieving the overarching goals of OCTRI 2.0. Responding to the challenges put forth in the IOM report to drive innovation in CTR, OCTRI’s Biostatistics, Epidemiology and Research Design component (OCTRI-BERD) proposes initiatives aimed at fostering methodology development, providing flexible personalized training experiences, and promoting professional development of BERD practitioners. In addition, OCTRI-BERD will further enhance the provision of collaborative and consultative services offered through our Biostatistics University Shared Resource, Biostatistics & Design Program. The Regulatory Knowledge and Support component proposes initiatives aimed at delivery of regulatory consultations services, training the workforce in human subjects’ protections, and alleviating regulatory-related bottlenecks in CTR. These efforts will further OCTRI’s missions and catalyze CTR regionally and throughout the CTSA network.