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University Research

University of Colorado Denver
 

Frequently Asked Questions


What is OnCore?
OnCore is a clinical trials management system (CTMS) developed and supported by Forte Research Systems, Inc.  OnCore supports clinical trial operations and includes the following functionality:
 
  • Manage protocols and subjects from study setup and activation through subject eligibility and enrollment to study closeout and reporting.
  • Maintain institution-wide oversight of subject safety.
  • Gain complete control over study financials — from budget negotiation to payment reconciliation.
  • Streamline staff workflows by tracking staff workload throughout a study with integrated effort tracking functionality.
  • Get granular control over clinical data and monitoring activities with sophisticated, yet easy-to-use, electronic data capture (EDC) functionality.
  • Quickly create an array of helpful reports. In addition to a rich collection of standard reports, custom reports are easily generated while respecting built-in security controls.
  • Paperless committee management for scientific review including Cancer Center specific Protocol Review and Monitoring System (PRMS) operations including electronic system for submitting, tracking, reviewing and approving trials though scientific review processes.
  • Streamlined reporting to Clinical Trials Reporting Program (CTRP) and ClinicalTrials.gov
  • Biospecimen management including inventory tracking and controls, requisition and distribution management and flexible annotation collection.
  
Why are we doing this?   
The NCI and NIH agencies that fund grants for the Cancer Center and CCTSI, in their review of our center and with revisions in grant guidelines, recommended that our institution needed a more robust clinical trial management system. We embarked on a lengthy process to evaluate vendor-supported CTMS’s on the market.  After an exhaustive evaluation and procurement (finding the money) process, OnCore was chosen as the CTMS that would best fit the needs of the research community today and to carry us into the future. 
 
What will happen to all the data in TES?    
We are preparing to move much of the data currently in the Cancer Center’s existing clinical trials database (TES) to OnCore to ensure as seamless a transition as possible. Wherever possible, for trials that meet migration criteria, protocol, subject, financial and regulatory, and biospecimen data will all be moved to OnCore. For departments that are not currently using a CTMS, no migration of data will be necessary and decisions about historical data entry into OnCore will be determined on a department-by-department basis. 
 
How will this affect me? 
Everyone who participates in the conduct of clinical trials will be affected by the implementation of OnCore in the long term. This includes research coordinators, data managers, finance and budget specialists, regulatory coordinators, investigators, bio-bankers, and administrators.  Many staff will have responsibility for entering data in OnCore, while others will rely on the data/reports that can be extracted from it.  Your level of day-to-day contact or involvement with OnCore will depend on your position and job duties. 
 
When will my department go live?
The official project kick off meeting was held on Dec 4-5, 2013. At this meeting, Forte staff come to our campus to learn about our particular needs and priorities for the OnCore deployment, and will include project stakeholders.  Following that, a detailed project plan has been developed.  Details about project timelines can be found on the Project Overview Page. Initial estimates for implementation include:
 
  • Third quarter 2014: OnCore is available for new studies for our early adopted
  • First quarter 2015: OnCore fully deployed in Cancer Center and Enterprise groups
  • Consolidate biobank management and clinical trial operations to OnCore for all CU research programs within 4 years of go-live. 
 
How will I get access to OnCore? 
All active users of the Cancer Centers existing system (TES) will undergo training and then be granted access to OnCore. A process of verifying user information including role and contact information will be undertaken by the project team to ensure all active users have updated information in OnCore at the time of go-live.
 
New users will be required to complete an access request form and attend training prior to gaining access to OnCore.  An access request form has been developed and will be available on the Request Access page of this website, where instructions for submission can also be found. 
 
What training will be required?    
Training will be required for all users before access to the system will be granted. The length and content of training will depend on the position and can range from 2-16 hours.  We anticipate training to begin in early 2015 for department using OnCore, and as needed for new departments coming on board.  Details of training required will be posted on this website on the training schedule page. 
 
Are there research coordinators, data manager, or other research staff involved in the OnCore project?
 
Research staff including coordinators, data mangers, physicians, regulatory, finance and others are all involved in the project as champions, subject matter experts (SME’s), and super users. They are included in the project to help design the system to meet the needs of researchers across the institution. A list of project team members, SME’s, and super users is available on this website on the Department Contacts page. You can also contact the project team at OnCore@ucdenver.edu.
 

 Frequently Asked Questions

 
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