As part of the overall mission to improve the efficiency and quality of the clinical trials conducted at RBHS, the RBHS Chancellor’s Office and NJACTS have invested in OnCore, a clinical trials management system.
Information about the Enterprise-wide Implementation of OnCore at RBHS
As part of the overall mission to improve the efficiency and quality of the clinical trials conducted at RBHS, the RBHS Chancellor’s Office and NJACTS have invested in OnCore, a clinical trials management system OnCore has been successfully used at CINJ for many years, but, with the enterprise-wide implementation, multiple enhancements are planned or are currently being implemented, including interfaces with eIRB and the electronic medical record systems.
What is a Clinical Trials Management System (CTMS)?
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.
What Clinical Research Studies Will OnCore be Used for (outside of CINJ)?
Outside of CINJ, OnCore will be used for studies meeting the following criteria:
- RBHS Faculty member as Principal Investigator
- Meets the definition of a Clinical Trial (https://grants.nih.gov/policy/clinical-trials/definition.htm ) or is a prospective observational 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 an RBHS location or partner hospital facility
Why Implement a Clinical Trials Management System?
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.)
How is OnCore Being Implemented Enterprise-wide at RBHS?
OnCore is being rolled out in a phased approach for Non-Oncology research at RBHS. The first phase began in February 2021 and involved the NJMS Clinical Research and the NJMS Infectious Disease clinical research group. The second phase will involve extension of the system to the RWJMS Clinical Research Centers, followed by additional clinical research groups on both campuses.
If you have questions about the roll-out time table, please contact Nancy Reilly, Exec. Director, RBHS Clinical Trials Office: firstname.lastname@example.org
How Does the Interface between OnCore and eIRB Work?
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.