Core-004

研究方法部分包括两个部分，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 OCTRI 2.0，每个组成部分都有明确的目标，并附有相关的具体目标 实现这些目标。所有研究方法的目标都与 OCTRI 的总体目标高度一致； 将衡量和评估每个模块对实现这些目标的贡献。两者都 各组成部分利用了 OCTRI 先前资助周期的成就，并利用了 OCTRI 的活动 对 OHSU 基础设施至关重要的成功单位（特别是生物统计和设计项目 [BDP] 和临床研究办公室），以确保高效、及时地实现目标。 近年来，在应对点击率挑战方面取得了巨大进步；然而，复杂的研究 系统需要创新的方法和流程来有效且高效地转化发现 纳入改善健康的干预措施。 CTR 的成功离不开以下方面的考虑： 研究伦理、研究设计、数据分析和解释。因此，致力于规划的核心， 在 OHSU 实施和实施高质量的 CTR 对于实现总体目标至关重要 OCTRI 2.0 的目标。响应 IOM 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组件 (OCTRI-BERD) 提出了倡议 旨在促进方法开发，提供灵活的个性化培训体验，以及 促进 BERD 从业人员的专业发展。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、生物统计和设计程序。监管知识和支持部分建议 旨在提供监管咨询服务、对劳动力进行人类受试者培训的举措 保护，并缓解点击率方面与监管相关的瓶颈。这些努力将进一步推进 OCTRI 的使命 促进区域和整个 CTSA 网络的点击率。

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.