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University Research

University of Colorado Denver
 

Project Overview


 

In 2012, the CU research community engaged in the process of evaluating a Clinical Trial Management System (CTMS) and selected OnCore (from Forte Research Systems, Inc.) as its preferred CTMS. In 2013 funding was secured which will provide a strong, centralized implementation and support structure for the project.  On 10/09/2013 the contract with Forte Research Systems (for OnCore) was finalized and the implementation project started.
OnCore will offer significant functionality in clinical trial management tasks across many types of trials and across the life cycle of research studies. OnCore provides an informatics infrastructure for managing research, including a wide range of operational components (clinical, regulatory, financial and administrative) and is designed to facilitate the complex work of conducting clinical research. OnCore has the capability to organize the many administrative tasks necessary to conduct clinical research, but is not limited to administrative operations. It also has the capability to enhance bio-repository activities related to specimen inventory and distribution management, facilitate committee review of new protocols, and streamline monitoring activities for investigator-initiated trials.
The OnCore Implementation project team is currently working on the implementation of the:
·        Clinical Research Management (CRM) module
·        Biospecimen Management (BSM) module
·        ePRMS
·        EPIC Demographics interface
·        InfoEd interface
·        Data Migration of Cancer Center data from the TES application for both CRM  and BSM
o   Data mapping
o   Data audits and clean-up
o   Building Calendars for all migrated trials
o   Building Budgets for specific migrated trials
 
The initial OnCore deployment will make the CRM module available to three enterprise (i.e., non-cancer) groups - Orthopedics, Ophthalmology, and Renal Medicine and Hypertension - and three CCTO protocols.  Protocols have been determined, staff has been trained and they will begin managing the selected trials in OnCore in the fourth quarter of 2014.
The Cancer Center’s CCTO teams and bio-bankers are scheduled to go live with the CRM and BSM in early 2015, after the relevant data has been migrated from Cancer Center’s legacy system (TES) to OnCore and calendars and budgets for migrated trials have been built in OnCore.  Additional enterprise groups will be brought onto the CRM in phases beginning in early 2015.
Check back here for updates.
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As part of the project planning and to provide the necessary ongoing support of OnCore, certain administrative tasks will be performed by the OnCore support team. While other tasks or activities will be performed by the individual research groups or teams. We've developed a diagram showing which activities will be performed by the OnCore support team and which by the research teams.    --Click here for the Diagram of Responsibilities- 
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