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If your protocol has a calendar in Oncore, a study team member will be required to complete the Budget Team Signoff before the calendar is released. This will need to be completed for each new calendar version needed created throughout the life of the study. To prepare for this signoff, study teams will need to ensure the following:

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If the above preparations were made, the staff listed as the Financial Coordinator on the protocol will receive the Budget Team Signoff Reminder Notice via email.  This indicates the calendar is awaiting your approval. Review and signoff should be completed as soon as possible because the calendar cannot be Released for use by billing staff or coordinators until this signoff and a few other steps that come after are completed. Once subjects are enrolled to the study, this task becomes more urgent to ensure billing compliance. Please take the following steps to complete your review.  See 

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1. Check that all of the following are true: 

   1. At a minimum, all visits with billable services (calendar procedures) occurring in a non-research designated area are represented in the Calendar and are labeled accurately.

      1. A PRN visit is added when there are billable procedures that will be done in a clinical area and will be billed to the study, but will not always occur at a defined Visit. The coverage analyst uses the financial agreement/funding information to determine which procedures should be included in this visit. This is very often determined by a Conditional /Invoiceable section of the Sponsor budget. You will need to verify that the coverage analyst has interpreted the intent of the contract language correctly into the Budget Grid.

   2. At a minimum, all billable services that will be done in a non-research designated area are represented in the Calendar.

      1. If billable services that will always be performed/analyzed (i.e. labs) in a research designated area and/or by a research team member with no billing credentials are included in the Calendar, they will have a Supporting Designation of (DRA) or (CL).

      2. Billable services that will be or may be done in a clinical area have one or more Charge Master Events listed underneath.  

      3. The associated services (i.e. anesthesia or laboratory analysis) that are not explicitly mentioned in the protocol are represented either as a separate service or as a Charge Master Event underneath a service or Charge Master Item underneath a Charge Master Event.

   3. All billing designations are correctly marked “S” or “R” and Supporting DesignationDesignations, if listed, are accurate.

      1. Any service listed in the contract as invoiceable “if not standard of care” should have a billing designation of “R” and a Supporting Designation of “TBD.” The Clinical Coordinator checking in visits for each subject will need to manually change this in the visit details for the subject if the service was medically necessary and NOT done SOLELY for research purposes.

2. If adjustments are needed, contact the WU Coverage Analyst listed in the Staff section of the PC Console (Menu > Protocols > PC Console on the horizontal Staff tab).

3. If everything looks correct, complete the Budget Signoff by following the below steps:

   1. While the protocol is pulled up in the Coverage Analysis page, navigate to the eCRF/Calendars Console from the Main Menu and click on Specifications. 

   2. Scroll to the bottom right of the page and click the button that says Budget Signoff. Do not complete the above review from this page because Charge Master Events/Items and Supporting Designations are not included here.

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• If a visit was entirely removed from the schedule in a new version of the calendar and that visit has already been verified, you will receive a warning pop-up.

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• The visit will not show on the subject's 'new version' calendar. You can find those visits in the Orphaned Visits tab on the Subject Calendar. 

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