OnCore and Epic Integration
Subject Safety
By integrating with Epic, OnCore can automatically flag research subjects enrolled in clinical studies, ensuring that their research participation is visible to healthcare providers.
Reduced Duplicate Data Entry
The integration eliminates the need for redundant data entry across multiple systems, as relevant research subject and study information can be securely shared between OnCore and Epic.
Billing Compliance
The integration between OnCore and Epic enhances billing compliance by ensuring that research-related procedures are properly flagged and billed according to the study protocol and sponsor requirements. This helps to maintain regulatory compliance and accurate financial tracking.
Improved Data Accessibility
Researchers and clinicians with defined access rights can access relevant subject data from both OnCore and Epic within their respective systems, promoting better communication and informed decision-making throughout the research and clinical care processes. OnCore is positioned to pull subject demographic data from EPIC and share study-related information that is needed in EPIC.
OnCore and CLICK Integration
Automated Study Information Transfer
Study information captured in CLICK, such as the study title, associated library (Cancer or Medicine), staff roles, and more, can be automatically populated into OnCore. This process will automatically create a protocol shell within OnCore.
Document and Review Synchronization
The integration of OnCore and Click will only transfer the study approval letter. All other documents will be manually uploaded by study staff within the PC console, or eventually pulled from eReg.
Staff Role Integration
To support the integration, CLICK will now include specific staff roles (see below). This will ensure that the proper staff roles are accurately documented in both CLICK and OnCore, enabling effective communication and notification workflows based on each individual's role within the research team, and assisting is study assignability.
A detailed table of IRB Field/Role and OnCore Protocol Staff Role Code mapping
| IRB Field/Role | OnCore Protocol Staff Role | Role Definition |
|---|---|---|
| Study Site Contact (Please select this role for the Primary Clinical Research Coordinator) | Study Site Contact | The point of contact for the study. Serves as the main communication liaison for a research site, coordinating interactions and logistics in the absence of a centralized study contact model. Identified as the contact on the Site Information Portal (SIP) page in OnCore, distinct from other roles due to their primary focus on site-level communication. |
| Primary Clinical Research Coordinator | Primary Clinical Research Coordinator | Acts as the lead in monitoring compliance and data quality in clinical trials. In OnCore, appears as the Protocol Contact, emphasizing their role in overseeing trial conduct, distinct from coordinators due to their monitoring and audit focus. |
| Clinical Research Nurse | Clinical Research Nurse | Specializes in patient care, usually in dedicated clinical research settings, administering treatments and monitoring health. |
| Clinical Research Coordinator | Clinical Research Coordinator | Person having responsibility for consent. Individual responsible for tracking receipt, distribution, dispensing, and final disposition of study-provided agents. Typically, a backup coordinator. |
| Regulatory Coordinator | Regulatory Coordinator | Site staff responsible for regulatory submissions and maintaining essential documents. |
| Principal Investigator | Principal Investigator | Investigator at the site responsible for signing the Delegation of Task List (DTL) for a given protocol and with overall responsibility for the study conduct at the site. |
| Study Chair | Study Chair | Leads the study’s guiding committee, overseeing strategic and decision-making processes. Appears in specific reports in CTMS, setting them apart as a high-level overseer, distinct from the hands-on roles like CRNs or CRCs. |
| Treating Physician | Treating Physician | Provides medical care to study participants, ensuring adherence to the treatment protocol. Identified in various forms in CTMS, distinct from nurses or coordinators due to their medical decision-making role. |
| Data Coordinator | Data Coordinator | Manages the collection and entry of data in clinical trials. QA and operational, they ensure that data is accurately recorded and maintained in accordance with the protocol. |
| Data Manager | Data Manager | Oversees the data management process, including data collection, validation, and analysis. They ensure the integrity and confidentiality of study data so accurate data can be extracted and valid/reproducible conclusions can be obtained. |
| Laboratory Coordinator | Laboratory Coordinator | Pathology lab support. |
| Sub-Investigator | Sub-Investigator | The person having responsibility for consent. Individual responsible for verification of eligibility. Individual responsible for assessing study end points. Investigator having responsibility for subject treatment (aka, Enrolling Investigator). Individual responsible for conducting physical exams and assessments. Individual responsible for writing patient treatment orders for IND agents. Responsible for assessing adverse events. |
| Research Advanced Practice Professional | Research Advanced Practice Professional | A healthcare professional, often with an advanced degree, who participates in the clinical research process, possibly involving direct patient care of specialized assessments. |
| Co-Investigator | Co-Investigator | Collaborates with the PI in the design, conduct, and reporting of the research. They may share some responsibilities with the PI. |
Data Consistency and Accuracy
By integrating OnCore and CLICK, research teams can maintain a comprehensive and up-to-date view of IRB study information, approval dates, the study approval letter, and personnel roles across both systems. This promotes data consistency, accuracy, and overall research efficiency.
Reporting and Analytics
Reporting and Analytics
OnCore provides robust reporting and analytics capabilities, enabling research teams to access comprehensive study data and generate valuable insights. With its powerful reporting tools, users can:
- Track study progress and accrual rates
- Monitor regulatory compliance and documentation
- Analyze resource utilization and financial performance
- Identify potential bottlenecks or areas for process optimization
- Generate reports tailored to specific needs
OnCore's reporting functionality streamlines the collection of data and metrics required for clinical trial start-up timelines, billing and financial operations, and National Cancer Institute (NCI) reporting requirements. Additionally, the system's integration with other institutional systems, such as EPIC, CLICK, and our financial systems, further enhances the reporting capabilities by allowing access to critical data. Report requests can be submitted to: OnCoreSupport@med.uvm.edu