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?
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
What will happen to all the data in TES?
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?
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
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?
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
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
Are there research coordinators, data manager, or other research
staff involved in the OnCore project?
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