Transforming Clinical Trials at the University of Michigan
  Week 36
October 12, 2017
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 - hosted at NCRC Building 300, Room 371
Enroll in training course using MLearning
Note: Enrollment Closes 2 business days prior to OnCore training.
  • CTMS-00202 OnCore Protocol Administration: 9:00 - 10:00am
  • CTMS-00201 OnCore Protocol Maintenance: 10:30 - Noon
  • CTMS-00303 OnCore Subject Management: 1:00 - 4:00pm
  • CTMS-00202 OnCore Protocol Administration: 9:00 - 10:00am
  • CTMS-00201 OnCore Protocol Maintenance: 10:30 - Noon
  • CTMS-00303 OnCore Subject Management: 1:00 - 4:00pm
  • CTMS-00303 OnCore Subject Management: 9:00 - Noon 
  • CTMS-00201 OnCore Protocol Maintenance: 1:00 - 2:30pm
  • CTMS-00202 OnCore Protocol Administration: 3:00pm - 4:00pm
Question:  
Could you tell me how you would go about adding (registering) a participant if they have been enrolled previously? We have a few participants who have either withdrawn or screen failed, but have come back and would like to participate. The OnCore system message is "This subject is currently registered to this protocol. This protocol does not allow duplicate enrollments." Is there a way to re-enroll participants?

Answer:
There is a "flag" located in the PC Console Management tab which defaults to NOT allow duplicate enrollment of subjects, but can be changed to allow such enrollment if this is an appropriate configuration for your protocol.

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Take the following steps to Activate the 'Allow Duplicate Enrollment' feature for your protocol:

1.    Ensure that the sponsor allows for duplicate enrollment.
2.    Submit a support ticket to clinical-support-service-desk@med.umich.edu  with  'Oncore - Allow Duplicate Enrollment' in the subject line. In the body of your email,  request that the 'Allow duplicate enrollment' feature be activated for  [Protocol  Number].  

This feature can be turned on by the OnCore Central Support Team through the Management tab in the PC Console and activating the 'Allow Duplicate Enrollment' checkbox.

NOTE: When the 'Allow Duplicate Enrollment' feature is activated for a protocol, subjects can be added to the protocol multiple times.  Each 'On Study' Date in the Subject Console > On Study tab will be counted as a separate accrual. When activating the 'Allow Duplicate Enrollment' feature for your study, it is important to inform your Finance Lead of this change.
 
Question: (CRA)
How do I register a subject into a protocol for a second time if the 'Allow Duplicate Enrollments?' flag is set to YES?

Answer:
To register a subject more than once to a protocol that allows duplicate enrollment, take the following steps:

1.    From the PC Console where you have selected your protocol, navigate to the SubjectsàCRA Console.
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2.    Select the Site from the drop-down list.

3.    Enter the subject criteria and click the 'Find' button to query the MiChart database.
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4.    Select the appropriate subject from the result of the MiChart search by clicking on the MRN link

5.    Click the 'Add' button to add the subject demographics into the registration screen.
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6.    Upon clicking the 'Add' button, OnCore will provide a popup box indicating the fact that the subject had previously been registered to this protocol. Click on the 'Continue' button.
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7.    Upon clicking the 'Continue' button, OnCore will register the subject to the protocol again. You will then be able to Consent the subject as you would a new subject to complete the registration.
NOTE: When you register a subject more than once in a protocol and sort the subject roster in the CRA Console by last name, you will see two records for the subject. Notice on the image below that the first instance of the subject record is highlighted in GREY providing a visual queue of the inactive record and providing an easy way to distinguish it visually from the active record for the subject.  
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Notice also that the Accrual Number remains the same until the subject acquires the 'ON STUDY' status. A duplicate subject enrollment will count towards an additional accrual once the subject as acquired the 'ON STUDY' status
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Using the new knowledge gathered since the Clinical Trials Support Units opened and OnCore went live, the Clinical Trials Support Office & OnCore Team brought together study coordinators as a continued commitment to harmonization and standardization of clinical trial workflows across U-M. As we successfully execute a diverse portfolio of trials, it is important that you all receive the focused training to understand your integral role and better defined responsibilities within the larger initiative.

Press to Launch
Super User of the Week: Tracey NaylorSuperUser

OnCore Role:
Administrator (Admin), Financial Coordinator (FC) and Protocol Coordinator (PC)

Position within CTSUs: 
Administrator for Behavior, Function, & Pain (BFP) and Children's (CHI)

Location: 

What's the best way to get in contact with you: 
Email

Why do you like being a Super User: 
I simply want to be able to support my units when they need it!

What is your favorite functionality of OnCore:
Access to reports where pertinent information is more readily available than it was with previous systems (or lack thereof).

What is a helpful tip you share with your end users: 
For study coordinators in particular, make sure you're checking off those visits as they happen (occurred) so that the finance team is notified of milestones met for invoicing and financial reconciliation/projection.

What are your hobbies outside of being a Super User: 
Spending time with the family doing whatever activities they are into (a husband and 3 daughters - 7, 6 and 3), planning Disney vacations, and farming! ;)
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.