CLINTRUSC Research Design Core (RDCD)

Abstract A critical component in in successfully conducting clinical and translational (C&T) research is to achieve the optimal standards of rigor and reproducibility of research methods, and the Research Design, Compliance and Data Management (RDCD) Core is strategically designed to achieve this goal by providing the infrastructure and expertise necessary for high-quality, innovative C&T research within the CLINTRUSC research network. With expertise in biostatistics, research study design, and electronic heath record (her), the RDCD core will provide C&T researchers across CLINTRUSC with training, consultation, and collaboration. Specifically, we will enhance research compliance by training and mentoring CLINTRUSC investigators/professional staff in conducting C&T human subjects research including observational and prospective studies (Aim 1); provide C&R researchers in the CLINTRUSC network with biostatistics and research design support including assistance with designing clinical and community-based study protocols, and performing sample size calculations, power calculations, and biostatistical analyses to ensure rigor and avoid methodological bias (Aim 2); and establish and enhance procedures to facilitate the use of EHR for research, including data acquisition, curation, management, and analysis (Aim 3). In addition, the RDCD Core will work in close collaboration with other CLINTRUSC Cores, including the Administrative Core (Aims 1-3), Professional Development Core (Aim 1), and the Health Research (Aims 2-3) Cores. The RDCD core will interact across CLINTRUSC network to ensure that RDCD expertise is effectively distributed across the entire CLINTRUSC in a manner proportional to the need for RDCD expertise. Metrics to measure impact of the RDCD Core include the number of 1) research consultations; 2) collaborative grant proposals submitted and funded; 3) collaborative manuscripts; 4) citations to this work; 5) workshops and seminars organized; 6) individuals put on local protocols; and 7) junior faculty researchers mentored. The RDCD Core’s underlying premise is that embedding RDCD expertise in CLINTRUSC in a transdisciplinary team science environment will elevate the quality of the research and facilitate a more rapid translation into improved health. To achieve this, the RDCD Core will promote leading-edge, innovative clinical, and translational research to ensure that scientific questions are addressed using optimally efficient, unbiased study designs and applying appropriate analytic approaches, cultivate expertise in C&T in biostatistics, data science, data security, data cybersecurity and artificial intelligence to support RDCD Core needs, and enhance research infrastructure. The endeavors will support the overall goal of CLINTRUSC: to positively impact population health by carrying out impactful translational research with the promise of improving evidence- based clinical medicine and public health practice.