Research Design, Compliance, and Data Management Core

Research Design, Compliance, and Data Management Core Project Summary / Abstract. Strong research design, data analysis, and study implementation expertise are key components of rigorous, reproducible, and impactful clinical and translational (C&T) research. Large health datasets, including electronic health records (EHR), combined with the procedures in place to ensure research is both ethical and compliant with NIH and institutional policies, provide C&T investigators with the capability to address a wide range of C&T research questions in a resource-efficient way. Although expertise and infrastructure are growing, there are critical gaps in Montana in each of these areas that the Montana Clinical and Translational Research Center (Montana CTRC), Research Design, Compliance, and Data Management (RDCD) Core is tasked with filling. These activities are critical to address health research priorities in Montana, a rural state with populations that experience substantial health disparities but who are underrepresented in C&T research. The overall objective of the RDCD Core is to support Montana CTRC investigators by providing expertise and resources in all phases of study protocol development and implementation with careful attention to adherence to federal and institutional research policies, rules, and guidelines. With RDCD support, we hypothesize that Montana CTRC investigators will produce rigorous and impactful research that addresses community priorities and establishes further capacity for C&T research in Montana. IDeA-focused program resources at the University of Montana (UM) provide an excellent platform to achieve goals and build C&T research capacity. Within the past decade, UM has built valuable capacity through two IDeA-focused programs: the Centers of Biomedical Research Excellence (CoBRE) Center for Population Health Research and the Montana site of the Environmental Influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network (ECHO ISPCTN). By collaborating closely with the Montana CTRC Cores and leveraging IDeA program-related resources, the RDCD Core will achieve three specific aims. Aim 1: Provide Montana CTRC investigators with the expertise needed to design and implement rigorous research protocols. Aim 2a: Leverage and enhance existing EHR to address community, partner organization, and investigator C&T research priorities. Aim 2b: Establish data navigation tools for clinical researchers that facilitate use of EHR and supporting datasets relevant to health research in Montana. Aim 3: Ensure compliance with NIH and institutional policies related to research in human participants and management of protected health information. In achieving these aims, the RDCD Core will foster the design and conduct of high quality and impactful C&T research, support Montana CTRC project success, and build capacity for future C&T research focused on health priorities in Montana.