Healthy Idaho Clinical and Translational Research Development Program Research Design, Compliance, and Data Management

PROJECT SUMMARY – RESEARCH DESIGN, COMPLIANCE, AND DATA MANAGEMENT (RDCD) CORE The Research Design, Compliance, and Data Management (RDCD) Core for the Healthy Idaho Clinical & Translational Research Development (CTR-D) Program will improve the rigor of clinical and translational (C&T) research and enhance the competitiveness of Idaho C&T research proposals by connecting academic expertise in study design and biostatistics while aligning access to electronic health records (EHR) data between academic and clinical affiliates (affiliate health system partners). Ingrained within our vision is the development and expansion of research design and data infrastructure that can be expanded across Idaho academic institutions and healthcare systems over time and will meet good practice and regulatory standards. To actualize the RDCD Core vision, four aims are proposed: (1) Assess investigator needs and offer training to develop competence in conducting C&T research; (2) Assist investigators in developing sound C&T grant proposals, research design, and study execution; (3) Develop and support a harmonized process to identify and utilize EHR data and develop a structured analytic environment that can be utilized by appropriately credentialed investigators statewide to conduct C&T research; and (4) Evaluate RDCD Core activities to assess performance, expansion, and inform future programming. Aim 1: The RDCD Core in conjunction with other Cores, will assess needs and offer training and resources to develop investigator competence in C&T research. RDCD-relevant topics will include fundamental concepts of study design, statistics, regulatory compliance, and others. Content will be delivered through live in-person, remote, and asynchronous platforms and updated annually. Aim 2: The RDCD Core will provide one-on-one assistance to investigators on C&T research design. Core biostatisticians will conduct analyses as requested for C&T researchers, and compliance personnel will assist investigators to identify and mitigate potential hazards and comply with Federal regulations. The RDCD Core will assist investigators in responding to protocol feedback provided by the HR Core or other grant reviewers. Aim 3: The RDCD Core will facilitate investigator utilization of C&T research data by establishing a process for investigators to identify and gain access to affiliate health systems EHR data including development of harmonized procedures for export, and utilization of data within an enclave for dataset analysis and curation. The Core will work with select clinical affiliates to develop and pilot a common data model (OMOP). Aim 4: Delivery of all RDCD Core activities will be evaluated. Assessments will be reviewed quarterly by the RDCD lead and associate lead and shared with CTR-D leadership committees. These evaluations will assess the delivery, quantity, and effectiveness of Core activities over time. These Aims will prepare scientists to conduct C&T research, develop competitive grant proposals, and collaborate across institutional settings that are of vital importance to the Healthy Idaho CTR-D Program and the state of Idaho.