Forte OnCore Clinical Trials Management System (CTMS)
After a period of information gathering and due diligence in product evaluation, the Dan L. Duncan Cancer Center (DLDCC) will be deploying Forte’s OnCore®, an enterprise-grade. Clinical Trials Management System (CTMS). OnCore will be available to priority clinical trials from DLDCC clinical investigators in a Pilot Phase ~ Spring 2014. Please check back to this website to follow the project’s progress, which will also be included within the DLDCC newsletter.
OnCore® CTMS Features
- Secure, web-based, database solution for clinical research
- Proven workflows based on extensive vendor and community domain expertise
- Customizable role-based permissions for all clinical research perspectives (e.g. principal investigator, study coordinator, monitor, data manager)
- Electronic Case Report Form (eCRF) creation, adaptation and reuse
- Calendaring, financials, regulatory, reporting, and other features supported.
Who Will Use OnCore® and How?
- All DLDCC programs and investigators, as well as research and regulatory staff
- Training sessions will be available for all end users
- Prioritized approach for implementation set by the DLDCC OnCore® Steering Committee
- Roll-out of new trials and migration of existing data for ongoing trials will be prioritized by the DLDCC OnCore® Steering Committee
- Process changes and streamlining are expected within the DLDCC Programs
Features for Pilot Phase
- Patient Registration for all trials
- Standard Reporting including NCI Summary 3 and 4, Clinical Trials.gov and Clinical Trials Reporting Program (CTRP)
- General regulatory support
- Integration with BCM Usernames & Passwords for BCM personnel
Additional features for investigators-initiated trials include:
- Eligibility and Pilot Randomization (Permuted Block)
- eCRFs / Electronic Data Capture (EDC)
- Study Activation and Calendar Workflows
- Support for Multi-Center Trials
- Support for New Clinical Trials created in OnCore
Subject matters experts from each DLDCC program, DLDCC CTSU and Regulatory officials acted as participants for an all-day project kickoff meeting, where each presenter gave a talk on their clinical trails work scope, goals and objectives, program organization, overview of the implementation process, and data management strategies.
OnCore® implementation teams attended a 2 day immersion training, to learn about configuration options available for the OnCore® system