Clinical Trials Management Systems Accounts & Support

COVID-19 UPDATE: Due to COVID-19, the Clinical Trials Support Office has worked across business partners to ensure uninterrupted support to research study work conducted at the University of Michigan. Click here to view resources that have been developed to support your clinical research workflow during this time. 

Access to OnCore

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 provides complete subject and financial management for all clinical trials at Michigan Medicine.  

In order to receive access to OnCore, you must submit an account request form. If you need clarification as to what role to submit a request form, click here. 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.

Modification or Deactivation of Accounts: The request form for OnCore may also be used to request account modifications or deactivation of an account. Deactivation should be requested as soon as you no longer require access to either application. 

Access to eReg

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, you will receive your eReg account information within two business days. 

Modification or Deactivation of Accounts: The request form for eReg may also be used to request account modifications or deactivation of an account. Deactivation should be requested as soon as you no longer require access to either application. 

Clinical Trials Management Systems (CTMS) Support

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

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!