Accessing data directly from Electronic Health Records (EHRs), known as electronic source data capture (eSource), can create efficiencies in the clinical research process whereby we can connect research with the provision of care.
The OneSource Project is a collaboration between investigators at the University of California San Francisco (UCSF) and the FDA with the goal of developing methods to automate the flow of structured Electronic Health Record (EHR) data into clinical trial electronic data capture (EDC) systems thereby reducing operating costs, saving time, and improving data quality for clinical trials. We have demonstrated an approach to transmit structured data from the UCSF EHR system to a clinical trial EDC we populated for a phase II clinical trial, (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2 (I-SPY 2 TRIAL)). This initiative is part of the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) portfolio.
OneSource leverages standards from Health Level 7 (HL7), Clinical Data Interchange Standards Consortium (CDISC), and Integrating the Healthcare Enterprise (IHE) for the capture and transmission of clinical research data. The goal of the work is to harmonize the data elements and implement better tools for data capture that could make these key elements available for healthcare providers and researchers connecting what was once two separate domains.
OneSource as a model for connecting clinical care and research leads to more effective, efficient use of clinical data for clinical research and decision-making, leading to cost reduction, time savings, and improved data quality for future clinical trials.
Slides: https://ucsf.box.com/s/spefgl6zgp7vw9sb75u5pjkt2g4dgre2 (MyAccess login required)
Some understanding of clinical and research systems, but not necessary
Adam Asare has over 15 years of experience in academia and industry developing clinical and research information systems. He serves as the Chief Data Officer at Quantum Leap Healthcare Collaborative and as the Director of Information Technology for the UCSF Breast Care Clinic overseeing efforts for process re-engineering and quality improvement of clinical care and research. The IT data management portfolio he oversees includes the I-SPY 2 TRIAL Electronic research systems, the OneSource/eSource platform collaboration with the FDA, the Clinical Trials Matching platform and the Athena Breast Health Network data systems.