Clinical Trials - OnCore

Launch App

HCI Research Informatics Shared Resource (RISR) has partnered with the Clinical Trials Office (CTO) in selecting and implementing the OnCore Enterprise Research system for Clinical Trials Management from Forte Research. This system provides tracking of all trials, reporting, patent accruals, and study calendar driven activities.

RISR has provided interfaces to the University Tracking of Clinical Research (uTRAC) implementation for their billing and compliance requirements, and to the Electronic Research Integrity and Compliance Administration (ERICA) IRB software system for up to date protocol status information.

Key Features include:

• Protocol Tracking – Creation and modification of all activities required for the protocol and full study calendar, including the schedule of tests, procedures medications, and dosages, and the status of the study. All types of clinical trials are supported including Cooperative Group, NCI-Sponsored, NIH, and Industry Sponsored trials.
• Patient Tracking – Ability to track patients on all the different studies which the CTO administers and ability to gather accrual numbers for all studies involving cancer patients at the university.
• Regulatory Information Tracking – Allows for complete data collection and monitoring of Phase I-IV trials and all study arms. The system facilitates oversight and reporting by all agencies responsible for regulation of human subjects research. each protocol includes a series of regulatory events, each of which goes through a cycle of submittal/approval of the appropriate regulatory group (IRB, CCIC, RDRC, Biosafety, Data Safety Monitoring Board, etc).
• Searching – Database-driven website, online searches, management reporting.
• Extensible Data Collection – Provides a means to collect customizable and extensible data for research protocols.
• Reference System Integration – Provides a common means to share and exchange information with CTRP (Clinical Trails Reporting Program), ERICA, and uTRAC.
• Accrual – Provides integration fro accrual submission from internally developed systems, including itBioPath, CCR, and Research Subject Registry.