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MedStar and Georgetown University have partnered with Forte Research Systems to implement a Clinical Trial Management System (CTMS), called OnCore. OnCore is a robust clinical trial management system and it includes all components of the clinical research lifecycle. OnCore will serve as a workflow manager and repository of all clinical research administrative and management activities. This new system represents a significant investment in our clinical research infrastructure and will greatly enhance and standardize our clinical trial management activities.
The implementation of OnCore across both MedStar and Georgetown will provide a unified structure for clinical research. The process of choosing a CTMS, planning, testing and the ongoing implementation began in 2014-2015.
As part of the phased rollout that was announced in Focus, we have continued to work with our associates to process study protocols and entered them into OnCore. Currently, OnCore is active for entry of all new studies and tracking for regulatory coordinators, but not yet open for patient visits and study information in all cases.
- Regulatory Coordinators have entered all of our existing studies that are currently open or in follow up in sixth months into OnCore, and continue to add new studies as they come down the pipeline. Study entry in OnCore includes study staff, sponsor, and IRB detail.
- Budget and Coverage Analysts are working hard to load study calendar and budgets for existing and new studies into OnCore. A third party vendor, Nimblify, has been contracted to support the study calendar build-out. Additional resources have been identified to support the entering of budgets for each protocol.
- Study Teams are gradually beginning to use it to track study patient data and study visits.
We have reached 100% of end-users for training, including all new hires. The training program continues with weekly engagement sessions for all associates who will utilize the system. There are also daily WebEx sessions for support of those trials that are open to accrual. It is the intention that all active studies will be using OnCore by the end of the summer. If you are not using OnCore regularly, please use the training environment in to maintain your skills.
As part of this roll-out, MHRI and Georgetown University Medical Center have been collaborating to create and implement joint policies and procedures to ensure that both entities are following the same protocols when utilizing the system. These policies can be found on the MHRI StarPort page, under the MedStar Georgetown sections.
We encourage all associates to support one another during this transition period, especially those colleagues who are most affected. Associates can find more information on StarPort, including documentation, training tools, and information for engagement sessions. If you have any questions, please contact Research@MedStar.net.