All clinical research being serviced by a CTSU will be managed in OnCore, an enterprise Clinical Trials Management System (CTMS). OnCore allows for automated standard interfaces with MiChart, which helps reduce duplicate data entry and integrates clinical research billing for increased efficiency and accuracy. OnCore has the ability to provide complete subject and financial management for all clinical trials.  

In order to receive access to OnCore, you must submit an account request form. After you have submitted your request and it is approved by your CTSU Account Approver, you will receive information about required training specific to your role. Once you have completed all training, you will receive your OnCore account information within two business days.

The Advarra eReg product is a compliant tool for managing all required regulatory documents for human subjects research. eReg integrates with the existing U-M OnCore CTMS, manages document owners and expiration dates, routes documents for signature or other notifications, and is 21 CFR Part 11 compliant for electronic signatures. eReg can share documents across multiple protocols and allows secure access for study sponsor monitoring. 

In order to receive access to eReg, you must submit an account request form. After you have submitted your request and it is approved by your CTSU Account Approver, you will receive information about required training. Once you have completed all training, including any OnCore training, you will receive your eReg account information within two business days. 

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Need assistance? Use the two steps below.

1. Start by using self-help resources available:
   • CTMS training materials – videos available through Cornerstone Learning 
   • CTSO Work Guides – thorough step-by-step guides that assist study teams with their clinical research workflow
   • Contact a CTMS Super User or speak with other users
2. Contact the Clinical Trial Management Systems (CTMS) Team. Click here, to submit a Request for Help. 
    

CTMS Super Users are CTSU Leadership, Portfolio Managers, Study Coordinators, and Finance Staff across the Medical School that provide assistance to our clinical research teams. Super Users take on additional duties to ensure migrations, configuration updates, upgrades, and long-term use in their departments are successful. Super Users provide peer-level application and change management support for their colleagues in order to enhance the successful implementation and adoption of the CTMS. Interested in becoming a Super User? Fill out the Volunteer Form!