Oklahoma Shared Clinical and Translational Resources

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1 ABSTRACT 2 Full integration of electronic health records (EHR) with research informatics promises to be a 3 revolutionary leap for the clinical and translational research (CTR) community and the public 4 health benefits this community aspires to attain. To date, far too many academic medical centers 5 (AMC) rely on disparate data systems that do not communicate well, inhibiting research 6 capacity and productivity. Barriers include limited capacities to identify and timely enroll 7 eligible patients in clinical trials, complex clinical trial workflows often requiring multiple 8 systems, manual review, and error-prone duplication, and an inability to expeditiously share 9 and consolidate data with external research partners. Fortunately, software tools that allay these 10 concerns are becoming widely available. The proposal describes 4 informatics innovations that 11 utilize Fast Healthcare Interoperability Resource (FHIR) technology to address key informatics 12 deficiencies that currently impede research growth. These innovations include (a) an interface 13 that integrates serious adverse event (SAE) information logged in EHR with the regulatory 14 forms of a clinical trial management system (CTMS); (b) implementation of the REDCap on 15 FHIR application to automatically populate chart abstraction information in to study case report 16 forms; (c) pilot test the EMERSE system for human-augmented electronic review of 17 unstructured medical notes; and (d) development of coding pipelines that delivery mCODE 18 standards to research quality cancer registries. These innovations seek to drive improvements in 19 patient safety, reduced burden of data collections, more efficient and equitable cohort discovery, 20 and greater agility and quality of external data sharing partnerships. The work proposed will 21 advance aims originally promoted in Oklahoma’s IDEA-CTR award. Specifically, the objectives 22 of the Biostatistics, Epidemiology, and Research Design (BERD) and Clinical Resources (CR) 23 Cores will be elevated with expanded capacity for clinical and translation research through (1) 24 greater access to clinical and epidemiologic research data via new cohorts, registries, and 25 repositories, (2) enhanced recruitment of patients to CTR studies, and (3) widely available 26 electronic regulatory assistance to OSCTR investigators and scholars.