OnCore is a clinical trials management system (CTMS) that will manage clinical research from start to finish, including building budgets, calendars for managing research billing and integration with Epic, and research participant tracking. Along with additional modules (eReg, Payments, and EDC), OnCore will provide the entire University research community with efficient processes to manage financial aspects and participant requirements that can also maintain a compliant environment at our institution. OnCore and its supporting modules can be leveraged alongside other systems that we currently use to share information across campus (Epic/Epic Research, ERICA, EDW, etc) and aid in recruitment. Reporting capabilities can allow us to strategically plan as research continues to grow at the University of Utah.
Using designated routing and workflows eREG will send documents, automatically alert study staff when new documents are submitted. This gives study teams, investigators, and the University of Utah the ability to increase regulatory compliance and increase efficiency while maintaining regulatory for binders, obtaining electronic signatures for protocol documents, creating and updating delegation of authority logs, etc. It's FDA 21 CFR Part 11 compliant.
Payments can be made easily by study coordinators to subjects by clicking one button. This reduces data entry time for study coordinators and time to payment for participants. This module allows for the study team to more easily track study finances using the available reporting features. The University of Utah can increase their compliance requirements by tracking study participants and income for tax purposes without extra efforts for the study teams.
Electronic data collection forms can be created and maintained within the system using the EDC module. This module is compliant with FDAS 21 CFR Part 11 security and integrity requirements. This allows study teams to minimize duplicative data entry, collect secure captures of signatures. Using a link with EPIC, clinical data can be shared directly into the forms. This reduces staff time and effort as well as errors in data collection. Shares data with EPIC automatically, increase efficiency in data collection and reduction of errors.