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- The Subject Status Milestone Screen Failed cannot be used, as it allows for only 1 set cost for all screen failures.
- In addition to the Screening visit, we would need a Screen Fail visit on the calendar with all the same procedures. The Budget Team would mark all the procedures as Pass Thru at the Screen Fail visit. The coordinator would need to N/A any procedure that did not occur at the Screen Fail visit. The Budget Team would then be able to invoice the sponsor for each procedure that occurred at the Screen Fail Visit.
- Example: A study has a screening visit that includes a Chemistry Panel, and EKG and an MRI. A subject can screen fail based on the Chemistry labs alone or can have adequate Chemistry labs, but screen fail based on their EKG results. Once a subject screen fails, they do not need to complete the other procedures required at the Screening visit, so the sponsor only pays for those procedures that actually occurred. Both the Screening and the Screen Fail visit would have the Chemistry panel, EKG and MRI, but the Screening Visit would be invoiceable at the Visit (Milestone) level and the Screen Fail visit would be invoiceable at the procedure level (Pass Thru).
Sample OnCore Subject Calendar:
Should this budget procedure be entered as a Protocol Related Event or as a calendar procedure?
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