University of California San Francisco (UCSF) https://www.ucsf.edu in collaboration with the Quantum Leap Healthcare Collaborative (QLHC) https://www.quantumleaphealth.org and FDA https://www.fda.gov have developed the OneSource System.
The system is an Electronic Data Capture (EDC) system, to seamlessly integrate clinical care and research data and is based on best practices and open-source EHR integration standards able to launch seamlessly within widely used EHR platforms.
The system is able to overcome current obstacles by enabling critical clinical data to be entered at the point of care, only one time, by the clinician and/or the patient.
The system automates transfer of data to labs on demographics and concurrent medications to clinical trials and registry data systems. This single entry then serves as the authoritative source and can be used many times, including for trials, quality improvement, and research.
The OneSource framework initially conceived at UCSF with FDA with the software further developed for production implementation by QLHC, has been implemented at eight sites of the QLHC sponsored I-Spy COVID Trial. By mid-2022, the goal is to have OneSource operational across 35 sites participating in I-SPY 2.2 (for breast cancer) and I-SPY COVID trials across the country.