Epidemiology and Clinical Research Informatics Shared Resource

Program Director/Principal Investigator (Last, First, Middle): Chu, Edward EPIDEMIOLOGY AND CLINICAL RESEARCH INFORMATICS SHARED RESOURCE PROJECT SUMMARY/ABSTRACT The Epidemiology and Clinical Research Informatics Shared Resource (ECRISR) serves a crucial role in support of both epidemiological and clinical trial research management by providing overall research management expertise and informatics-based management solutions to MECC investigators. ECRISR has extensive experience supporting all aspects of epidemiological research with a focus on the development of Study Management Systems (SMS), which facilitate the diverse management, data, and operational aspects of implementing complex protocols. SMS incorporates automated workflow processes across shared facilities, implement Quality Assurance (QA) and best practices in order to ensure data integrity, automate data integration from various sources, and establish real-time data monitoring to provide efficient research operations, improved data access, and progress/regulatory reporting. SMS integrates with internal and external Electronic Health Record and laboratory systems, and support management of multi-center clinical research projects. ECRISR is responsible for the development, implementation, and oversight of a comprehensive clinical trial and research management process to standardize and streamline MECC clinical trial and research process management. This shared resource has extensively customized the functionality of the Velos eResearch Clinical Trial and Research Management System (CTRMS) to provide QA oversight and facilitate compliance/monitoring of all clinical trial activity. ECRISR has established workflows, policies, and procedures that collaboratively engage, guide, and/or provide oversight to other shared resources. The research management process spans the lifecycle of protocol management from IRB submission to completion and the ECRISR continually expands the purview of the overall process with the design of custom interfaces between the CTRMS, EPIC, and multiple IRB institutional systems to provide fully integrated regulatory and operational management of clinical trials. ECRISR provides competency and capacity to develop scalable and robust informatics infrastructure that leverage big-data analytic resources to enable a wide spectrum of research. This shared resource maintains a sophisticated applications framework with data governance and security protocols in compliance with national standards and provides interoperability with other systems to create patient-centered, integrative informatics platforms for comparative effectiveness and preventive care research. We provide novel solutions in the realm of data extraction and QA. ECRISR strives to foster interdisciplinary collaboration, serves as a data coordinating center, provides data management services, assists in the development of pilot and grant proposals, and works closely with biostatisticians in the production of complex databases and publications. OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page