Let’s start with a definition:
EHR to EDC, also known as eSource and EHR-to-EDC integration, is the process of combining electronic health records (EHR) with electronic data capture (EDC) systems to improve data accuracy, workflow efficiency, and overall decision-making during clinical trials.
Key results of EHR-to-EDC integration include the elimination of manual data entry, far fewer data entry errors, real-time health record access, and enhanced cybersecurity and interoperability measures. In short, EHR eSource benefits all clinical trial stakeholders – sponsors, academic research organizations, contract research organizations, sites and site networks, and even patients. To learn more about the many advantages of EHR to EDC eSource in clinical trials, read Ben Baumann’s blog.
EHR-to-EDC Integration in Clinical Trials Delivers Results
Direct data capture is transforming clinical trials. Just ask the folks from the I-SPY-COVID-19 platform trial.
OpenClinica’s EHR eSource solution – then called OneSource and now named Unite™ – was launched within each patient’s medical chart in the EHR. It automatically populated structured electronic case report forms (CRFs) with the exact data required per the protocol, without the need for manual abstraction.
Deployed at eight major health systems in the multicenter, adaptive phase 2 I-SPY-COVID-19 platform trial, Unite delivered time savings of 61 percent over sites using manual data abstraction. Even better, data errors were eliminated at sites using Unite, leading to additional downstream cost savings in source data validation (SDV) costs and query resolution. Unite has the added benefits of low implementation costs and reusability across sites.
For a deep dive into the success metrics from the I-SPY-COVID-19 platform trial, download the case study here.
How Does EHR-to-EDC in Clinical Trials Work?
EHR-to-EDC in clinical trials – also known as eSource clinical trials – uses secure, standards-based technology to direct data capture from trial participants’ medical records, found within EHRs. The secure bridge between healthcare and research eliminates manual data transcription and is especially suited for rigorous GCP and Part 11-compliant clinical trials.
Major EHR vendors such as Epic and Cerner back the technology, in part, because the standards are mandated through a set of regulations, the 21st Century Cures Act, the HITECH Act, and the Office of the National Coordinator for Health Information Technology (ONC) certification criteria.
EHR to EDC does not require any software implementation or complex configuration at the site level. In fact, for OpenClinica’s eSource solution, Unite, only 15-20 hours are required for configuration at the hospital administrative level. Following this initial set-up process, it takes 30 to 90 minutes to bring each site online.
Unite is currently available at 450+ clinical trial sites serving millions of patients, and our network continues to expand. Major health systems now in the Unite EHR-to-EDC network include:
- Columbia University Medical Center
- MD Anderson Cancer Center
- Penn Medicine
- Sanford Health
- UC San Diego School of Medicine
- Yale New Haven Health
How Does EHR-to-EDC Leverage SMART on FHIR?
SMART on FHIR is a technology framework for apps to integrate with EHRs in a way that is reusable, platform independent, and, in the US, has been widely adopted and supported by EHR vendors and healthcare providers. It provides a very consistent way to integrate data across the many sites that are usually part of a clinical trial.
SMART on FHIR is the technology backbone that enables researchers to use one click to securely launch the eCRF from the EHR patient chart and automatically populate the eCRF with source data. It’s also why many therapies are able to get through clinical trials safer and faster, which in turn, benefits the patients who need them.
Want to know more about the near-term and long-term future of SMART on FHIR look like? Watch an excerpt of my interview with Applied Clinical Trials here.
Still have EHR to EDC integration questions? Reach out to us at the contact page and we’ll be sure to get you answers.