Transforming Clinical Trials at the University of Michigan
  1 Year Anniversary
February 1 , 2018
IN THIS ISSUE


Do you have a colleague interested in the OnCore TUTOR, but not yet an OnCore user? Have them sign up for the TUTOR (and any other Office of Research Newsletters)! 

Check out the OnCore TUTOR archive for a previous edition!
Upcoming Training Opportunities training

OnCore Training -  Enroll in training course using MLearning
Note: Enrollment closes 2 business days prior to OnCore training.
LOCATION: NCRC Building 10, Room G062A
  • CTMS-00203 OnCore Protocol Administration: 9:00am - 10:00am
  • CTMS-00201 OnCore Protocol Maintenance: 10:30 - Noon
  • CTMS-00303 OnCore Subject Management: 1:00pm - 4:00pm
LOCATION: NCRC Building 10, Room G062A
  • CTMS-00203 OnCore Protocol Administration: 9:00am - 10:00am
  • CTMS-00201 OnCore Protocol Maintenance: 10:30 - Noon
  • CTMS-00303 OnCore Subject Management: 1:00pm - 4:00pm
Help
1.  Login to OnCore and select your name in the upper right cornor of the screen. 
2.  Click  Help from the dropdown user menu.
Doucment an IRB Amendment Review (2 step process) CRA

Step 1 - Record Amendment Submission in OnCore (Submission)
1.  Login to OnCore and navigate to  PC Console > Reviews .
2.  To document submission of an amendment for IRB review, click the IRB horizontal tab.
3.  Click Add.
Click to Enlarge
4.  Enter the following U-M required* fields:
  • Submit Date*: Enter the date the amendment was submitted in eResearch Regulatory Management.
  • Review Reason*: From the drop-down list, select Amendment.
5.  Click Submit and Close.

Step 2 - Update IRB Approval (Outcome)
1.  Navigate to PC Console > Reviews.
2.  To document the outcome of an IRB review for the amendment, click the IRB horizontal tab.
Click to Enlarge
3.  Click Edit in the amendment box.
Click to Enlarge
4.  Enter the following U-M required* fields:
  • Action*: Enter the IRB decision.
  • Action Date*: Enter the IRB "Approval Date" found on the official letter sent to the study team by the IRB. If a central/commercial IRB is used, this is the date of their approval not the date of IRBMED acknowledgement. Note: This date is not the date the study team receives notification from the IRB.
  • The Expiration Date should not change due to an amendment.
5.  Then click Submit and Close.

See Document an IRB Amendment Review Workguide for more information.

The documents below have been reviewed and approved for publication by the relevant parties. Please take a moment to familiarize yourself with these changes - we encourage you to discuss these changes with your colleagues to ensure understanding. Have further questions? Contact OnCore Support at  Clinical-Support-Service-Desk@med.umich.edu
Document Title
Summary of Changes
Audience
  • Added Summary Accrual information
  • Provided required fields clarity
  • Added 'Summary Accrual' workflow
  • Added pop-up window inform that asks for confirmation of the CTSU Administrator's and CTSU Medical Director's Review Decisions.
  • Added additional content to clarify when an 'approved-with-contingencies' case moves from the active tab to the pending tab
  • New Workguide
  • Added Summary Accrual information
  • Provided required fields clarity
Financials: Invoicing
  • Added pass thru items to an invoice
  • Clarified visit variations  
Applying Payments for Cost Reimbursable Budgets
  • Clarified "Date Received" and "Date Reconciled"
  • No special characters in receipt
Applying Payments for Fixed Priced Budgets
  • Clarified "Date Received" and "Date Reconciled"
  • No special characters in receipt
Feasibility Submission Tip Sheet
  • Added Summary Accrual information
  • Provided required fields clarity
     
Super User of the Week: Elizabeth WuSuper_user

Role within OnCore:
Protocol Coordinator (PC), Clinical Research Associate (CRA)

Position within CTSUs:
Clinical Research Project Manager, Ambulatory & Chronic Disease CTSU

Location:
1044 MBNI

What's the best way to get in contact with you: 
Email (elizwu@med.umich.edu) or phone (734-764-4048)

Why do you like being a Super User:
Being able to help study teams, and if I can't figure it out, I'll find the answer for you! 

What is your favorite functionality of OnCore:
Those task lists help keep me organized. 

What is a helpful tip you share with your end users:
Don't forget to check off your study visits in OnCore in real time. It really will help you and the finance team.

What are your hobbies outside of being a Super User:
Eating ramen and sushi, and traveling.
Need Support? We're Here to Help! support

The OnCore Team offers at-the-elbow and phone support! Reach out via the clinical-support-service-desk@med.umich.edu email address and request a time on your schedule, at your location! If you would prefer a screen sharing session, please indicate this within the body of the ticket. Specify a few dates and times that would work for you!
  1. Utilize Self-Help Resources such as workguides, training materials, OnCore Learning Portal and Super Users, or other OnCore Users.
  2. Please contact clinical-support-service-desk@med.umich.edu, subject "OnCore", for your support questions. Alternatively, call 734-936-8000 (Option 2) 
  3. HITS will forward the ticket to the OnCore Team who will help you resolve OnCore task-related questions or requests for system configuration changes (add sponsor name, drop-down updates, new privileges, etc.) and custom reporting.


Our mission in the  Clinical Trials Support Office  is to support faculty and staff at the University of Michigan Medical School as they work to create the new knowledge needed to improve clinical care, value, and health outcomes by successfully executing a diverse portfolio of high-quality clinical trials.