Core-004

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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.