Overview
OnCore is the enterprise-wide clinical research management system at VCU and VCU Health. The web-enabled system provides a centralized database for research teams and relies on role-based security to control study data access. The system is integrated with Cerner, VCU Health's electronic medical record, to alert clinicians of patient participation in research studies. It also records and monitors clinical trial participant consent, interventions, and safety, and reports adverse events through Cerner. OnCore collects study, participant, and procedure data to enhance clinical trial participant safety, provide accurate institutional metrics, improve research billing compliance, and increase sponsor funded cost recovery.
OnCore electronic Case Report Forms
OnCore is enabled to collect subject study data through electronic Case Report Forms (eCRFs). The forms are linked to the clinical trial participants’ calendars and made available to research coordinators to input data as visits occur. eCRFs may be assembled to include data validation components, which allows for increased data entry quality. Centralized form creation provides an extra layer of oversight and standardization. Access to eCRF data is controlled through unique usernames and role-based security.
Protected Health Information in OnCore
OnCore is categorized as a VCU Affiliated Covered Entity (VCU ACE), which allows the system with access to protected health information (PHI) through the conduct of standard business operations. This access is provided through the HIPAA authorization of all units included in the VCU ACE. As the study relates to medical treatment, a minimum amount of PHI will be collected in OnCore to support internal VCU processes related to participant safety and accurate study billing.