OnCore

OnCore is a web-based enterprise-wide clinical trials management system (CTMS) that will simplify clinical research management and integrate multiple functions, including protocol administration, participant tracking, and sponsor invoicing. The OnCore CTMS will align with the Emory Healthcare Epic electronic medical record system to reduce redundancy across the enterprise and enhance patient safety and research billing compliance.

Studies requiring management in OnCore are the following:

• All studies with Emory Healthcare or Grady billable items or services - regardless of sponsor/funder - requiring a Prospective Reimbursement Analysis (PRA) or Coverage Analysis (CA)
• All studies that meet the NIH clinical trial definition regardless of billables (including interventional)
• All studies where the Office for Clinical Research (OCR) performs the invoicing (mainly industry/hybrids)
• All cancer-related, prospectively enrolling studies

If your study is not listed in the categories above, you can enter a shell protocol in OnCore CTMS. Shell Protocols can be created with no calendar, coverage analysis (CA), or budget but allow study/subject coordination as needed.

Who will use OnCore?

Anyone involved with clinical research protocol, participant, or financial management responsibilities for eligible Emory studies will utilize OnCore.

How can I get trained?

Starting in December 2024, Department OnCore Superusers will complete OnCore CTMS training and instruct their staff on navigating OnCore consoles for protocol, subject, and financial management for 2.0 and moving forward. Each OnCore Superuser has signed an attestation to adhere to training and support by verifying training, acknowledging responsibilities, committing to data integrity, and maintaining compliance. For more information about OnCore, visit the OnCore SharePoint site. View a list of Department OnCore Superusers, version 12-04-24.

Department Oncore Superusers are to complete the following steps below before training your staff:

1. Register in Emory LMS Brainer via Self-Service > Learning Management > Brainer.
   • Search for "OnCore CTMS, 2.0 Superuser Training Track." 
     • Step 1: OnCore CTMS Superuser Attestation and Training Verification Form.
       • If any eLearning modules were completed in Advarra University, upload them in this form for Emory LMS Brainer credit.
     • Step 2: OnCore Feature Guide.
     • Step 3: OnCore 115: Document a Basic IRB Review.
     • Step 4: OnCore 210: View and Manage Participants in the CRA Console.
     • Step 5: OnCore 230: Subject Registration.
     • Step 6: OnCore 240: Consent and Eligibility.
     • Step 7: OnCore 250: On Study.
     • Step 8: OnCore 260: Subject Calendars.
     • Step 9: OnCore 270: Other Subject Visit Tools.
     • Step 10: OnCore 330: Additional and Unscheduele Calendar Events.
     • Step 11: OnCore 570: Task Lists Overview.
     • Step 12: OnCore 575: Task List Administration in a Protocol.
     • Step 13: OnCore 580: Task Management Administration.
     • Step 14: Register for one of the 3 hours of OnCore CTMS, 2.0 Superuser Training in Brainer.
     • Step 15: Complete the 1/6 and 1/7 Advarra sessions. (Due to capacity requirements, 25 of the 68 OnCore Superusers have been pre-registered and notified by Advarra. However, others will complete this training via a recording.)
     • Step 16: Complete Simulation Check-Off in Brainer. Available in January 2025 after Advarra sessions.
       
     • FINAL STEP: The EHI Digital Informatics Team will verify training for continued OnCore access.
       

 *Note: The following Advarra eLearning modules were prerequisites from OnCore, 1.0 Training with Karen Browning, Sr. Research Services Consultant, between October 2022-to-October 2024.

1. OnCore 100: Navigation eLearning.
2. OnCore 200: Introduction to Managing Subjects.
3. OnCore 220: Subject Console and Companion Protocols.
4. OnCore 230: Subject Registration.
5. OnCore 260: Consent and Eligibility.

 If you have not completed the list above, you must complete them in addition to the above steps in Emory LMS Brainer >Learning Management > Brainer,  which are searchable by the name.

Curriculum:

• Module 1: Study Team Enterprise Workflow, Features, Navigation, and IRB Basic Documentation 

• Module 2: CRA and Subject Console [Subject Registration + Amendment Calendar Version].  

• Module 3: Financials Console, Closeout, Reports, and Amendments [including CA attachments, Protocol-Related, Subject-Related, Invoiceables].  

• Module 4: Advarra will provide a refresher, which is TBA. 
  

• Module 5: Emory LMS Brainer module -  Simulation Check-Off of specific tasks in OnCore CTMS.
  

Utilize the following PowerPoint Presentations as a guide to train your staff. Modify them as needed.

OnCore Superuser Training Dates

Below are the training dates for OnCore Superusers on Step #14. Please ensure Steps #1-13 are completed before registering. You must register for a session by Friday, November 29, 2024.

Non-OnCore Superuser Training Dates

Below are the training dates for existing and new OnCore users, who will be trained by your department's OnCore superuser. You must complete all steps below.

1. Register in Emory LMS Brainer via Self-Service > Learning Management > Brainer.
   • Search for "OnCore CTMS, 2.0 User Training Track." 
     • Step 1: OnCore Feature Guide.
     • Step 2: OnCore 100: Navigation (Optional in Brainer if completed in OnCore 1.0).
     • Step 3: OnCore 115: Document a Basic IRB Review.
     • Step 4: OnCore 200: Introduction to Managing Subjects (Optional in Brainer if completed in OnCore 1.0).
     • Step 5: OnCore 210: View and Manage Participants in the CRA Console.
     • Step 6: OnCore 220: Subjects Console and Companion Protocols (Optional in Brainer if completed in OnCore 1.0).
     • Step 7: OnCore 230: Subject Registration (Optional in Brainer if completed in OnCore 1.0).
     • Step 8: OnCore 240: Consent and Eligibility.
     • Step 9: OnCore 250: On Study.
     • Step 10: OnCore 260: Subject Calendars (Optional in Brainer if completed in OnCore 1.0).
     • Step 11: OnCore 270: Other Subject Visit Tools.
     • Step 12: OnCore 330: Additional and Unscheduele Calendar Events.
     • Step 13: OnCore 570: Task Lists Overview.
     • Step 14: OnCore 575: Task List Administration in a Protocol.
     • Step 15: OnCore 580: Task Management Administration.
     • By 1/6/2025, receive training from your Department OnCore Superusers. Department Oncore Superusers must complete your training.
     • Step 16: Upload CITI Health Privacy and Information Security (Upload CITI Certificate of Completion.)
     • Step 17: Complete Simulation Check-Off in Brainer. (Available in January 2025).
       
     • FINAL STEP: The EHI Digital Informatics Team will verify training for continued or new OnCore access.

If you have any questions, please contact OCR at OCR@Emory.edu or 404-778-4960.