OnCore

A Clinical Trial Management System (CTMS) is a web-based software system used to manage clinical trials, not only from the institutional perspective, but also at the level of the individual investigator/study coordinator and department.

Access to OnCore is typically needed for staff members who are involved in conducting clinical research. The most common staff roles in OnCore are research coordinators or assistants, research nurses, regulatory coordinators, pharmacists, and the research financial team. Principal Investigators and other research team members are also welcome to request access.

To request access for OnCore, fill out this form. Prior to being granted access, users will be assigned the relevant training modules through Advarra University. These are self-paced, guided webinars, catered specifically to your role. The amount of training required varies based upon role, but typically takes 2-4 hours.

After Advarra University training, the Clinical Trials Office team is available to meet with research staff via video conference for individualized training. For regulatory members, this will include a demonstration of how to submit a study into OnCore via ePRMS. For coordinators and other study team members, this will include a demonstration of how to register a subject and document a visit. For the finance team, this would involve a demonstration of how to generate invoices and complete study account reconciliation.

The CTO staff are always available for continual OnCore support, with scheduling available by going to go.rutgers.edu/CTOSupport.

Outside of CINJ, OnCore will be used for studies meeting ALL of the following criteria:

• Rutgers Health Faculty member as Principal Investigator
• Either of the below study types:
  • An NIH-defined clinical trial (https://grants.nih.gov/policy/clinical-trials/definition.htm)
  • Non-interventional study which entails/requires billable clinical procedures (i.e. procedures associated with a CPT code, such as a CT scan, MRI, clinical laboratory testing)
• To be implemented locally at a Rutgers Health location or partner hospital facility

From an institutional perspective, we anticipate that, by implementing OnCore, RBHS will be able to:

• Streamline and standardize our clinical research workflows in order to improve efficiency (particularly with regard to study start-up processes, such as contract/budget negotiation, Medicare Coverage Analysis, partner hospital agreements and IRB/regulatory submissions)
• Gain visibility into the clinical trials conducted across the enterprise for tracking and reporting purposes
• Enhance current processes to ensure patient safety, regulatory compliance and clinical research billing compliance

From a school or department perspective, OnCore will enable:

• More efficient management of clinical research personnel time and effort
• Improved budgeting and financial tracking, including sponsor invoice tracking

From the Investigator and Study team perspective, OnCore will help to:

• Track study start up tasks and timelines
• Assist with managing participant visits and help assure completeness of data collection
• Facilitate regulatory compliance (i.e. adverse event and deviation reporting, re-consent, etc.)

Click Here for the standard Industry Startup Workflow.

Certain OnCore functionality is driven by ensuring compliance with applicable regulatory procedures, such as IRB reviews. The purpose of the interface is to reduce duplicative data entry and allow easy visibility of IRB reviews in OnCore.

To reduce coordinator burden:

• eIRB will import all relevant protocol information from OnCore into eIRB, such as protocol titles, staff, protocol number, sponsor, etc.
• eIRB initial reviews, continuing reviews, modification requests and reportable event forms will automatically flow from eIRB to OnCore.
• Study status (i.e. approved, withdrawn, closed, etc.) will be automatically updated in OnCore
• eIRB expiration Dates will flow from eIRB to OnCore.

The Clinical Trials Office has worked collaboratively with the Cancer Institute of New Jersey to make enhancements to OnCore in support of reducing time and effort with respect to duplicative work.

i.     Research subjects’ demographic data will now be pulled directly from Epic. Simply enter an MRN, or last name and DOB to retrieve all the subject’s demographic data for use in OnCore. Once linked, all OnCore demographic data will remain up to date through an interface with Epic. Demographic updates in Epic are sent to OnCore nightly.

ii.     The study profile created in OnCore is also sent to Epic in an effort to enhance patient safety, reduce duplicate work, and facilitate billing compliance. Prior to a study opening to accrual, the Clinical Trials Office will send the study profile to Epic. This sends the basic study information (such as Study short title, PI, and coordinator names, etc.) and automatically links each future study participant to the study record in Epic. This ensures that subjects have a research flag on their profile in Epic, which will enhance patient safety. Ultimately, an additional interface between the two systems will facilitate grouping standard of care and pure research charges appropriately.

iii.     Additional integrations with Epic are being explored and are continually assessed to simplify the OnCore & Epic experience.