By itself, OnCore, Yale’s comprehensive clinical trials management system (CTMS), has a high level of functionality that eases the burden of conducting clinical research. As a leader in the integration of an EHR with a CTMS, Yale stands on the cutting edge of defining new industry standards to create a bi-directional interface. This integration has benefited clinical research at Yale and other institutions around the country.
Yale has worked with Epic and Forte Research Systems, the makers of OnCore, to define national standards for integrating research functions. These standards support an interface that moves information from the EHR to the CTMS, including:
- Demographic and laboratory data.
- Clinical research data.
- Patient enrollment and consent status.
- Serious adverse events.
- Clinical research billing and revenue management.
Data documented in the EHR by the clinician are automatically pushed to the CTMS and autopopulate case report forms for data collection and reporting. Integrating data can improve patient safety; allow for complete transparency; help with the management of timely reporting to regulatory authorities; and ensure appropriate clinical care for research subjects, especially if they have an adverse event related to a study intervention.
The Yale OnCore team is also working to build patient-facing questionnaires in MyChart for patient data collected throughout the life cycle of a clinical trial. These can be done prior to or during the study visit; it’s convenient for patients and translates to more efficient workflow for study staff. This information can also be moved into the EHR where clinicians can view it, as well as into the CTMS, where it can be used for data collection.
Collaborating with Other CTSA Sites
This will change the landscape for reporting to funding agencies and institutional reporting.
YCCI Chief Operating Officer Tesheia Johnson, MBA, MHS
Fellow CTSA institutions have leveraged Yale’s standards-based approach to integrate clinical research management systems with EHRs, and Yale has been eager to share lessons learned. Through regular phone calls and a face-to-face meeting, Yale’s OnCore team members shared with their UCLA counterparts how they planned the interface and workflow, as well as how they developed and implemented fee schedules, calendar builds, and other sets of functions. Such collaborations highlight how Yale’s pioneering work with emerging data standards is helping to improve patient safety, reduce errors, and improve the research environment for institutions around the country, regardless of the systems or vendors they use.
Yale is leading an initiative with Forte to develop the Research Evaluation System (RES), an enterprise-wide system to track metrics around the CTSA and more than 20 other NIH center grants. While some centers have their own tracking systems for specific center grants—UCLA has one for cancer that includes grants, publications, membership, and core use—RES is a comprehensive enterprise-widetracking system that includes not only these metrics but also institutional support and investments; pilot grants; community projects; such data related to trainees as educational outcomes, awards and collaborations; patents; and survey data. RES also contains such innovative functions as the ability to pull publications directly from PubMed, and the ability to store and collect success stories that are critical to funding applications and reporting. Accessibility to these data in a single system greatly facilitates and eases the burden of institutional and grant reporting. Yale was the beta site for RES 1.0 and 1.5, which included the loading of 10 years of Yale evaluation data. RES 2.0 incorporates lessons learned from the beta implementation; lessons learned from UCLA’s system; and input from several other cancer centers and CTSA sites.
“This will change the landscape for reporting to funding agencies and institutional reporting,” said YCCI Chief Operating Officer Tesheia Johnson, MBA, MHS. “It’s the kind of innovation that will have a bigimpact on the way our investigators and research staff work by allowing them to track their progress and understand what’s successful.”
Optimizing IT platforms that support research is an ongoing task that requires the collaboration of multiple institutions and vendors. Going forward, YCCI will continue to evaluate the functionality and integration of the CTMS and EHR, and to spearhead improvements that facilitate research across the national research community.