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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.
- For each visit where a subject can screen fail, we can include a duplicate screen fail visit on the calendar. The budget team would set these screen fail visits up as Milestones with the amount the sponsor will pay for each. The coordinator will log the screen fail version of the visit if the subject screen fails at the visit; otherwise, they will log the regular visit and mark the screen fail version of the visit N/A.
- Example: There are 2 steps to determining eligibility on a study, so there is a Step 1 Screening Visit and a Step 2 Screening Visit. The sponsor pays $850 for a Screen Failure at Step 1 and $500 plus the cost of the Step 1 Screening Visit for a Screen Failure at Step 2. The OnCore calendar will need the following 4 screening visits: 1) Step 1 Screen, 2) Step 1 Screen Fail, 3) Step 2 Screen, and 4) Step 2 Screen Fail.
Sample OnCore Subject Calendar:
The sponsor pays per procedure during Screen Fail visits, so there is no set cost for a Screen Fail.
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Sample OnCore Subject Calendar:
A study allows a subject who does not meet eligibility criteria at the Screening visit to re-screen within a certain timeframe without being considered a Screen Failure.
- In this instance, you would not want to mark the subject ineligible in OnCore after they do not meet the eligibility criteria at the first visit Screening visit since they plan on completing a rescreening visit within the allowed window. You would need to document that the subject completed a 2nd screening visit within the same registration.
- We would build a Re-screening visit into the calendar with the same procedures as the Screening visit. The Budget Team would set up this Re-screening visit as a Milestone with the amount the sponsor will pay. The coordinator will log the Re-screening visit if the subject re-screens within the allowed time frame without requiring a new registration and consent; otherwise, they will mark the Re-screening visit N/A.
Should this budget procedure be entered as a Protocol Related Event or as a calendar procedure?
- If the budget event is not related to a specific subject then it should be added to the Protocol Related tab. Ex: QoL Survey Training for Coordinators. The sponsor pays for time spent training coordinators on how to administer the QoL survey to subjects on the protocol. The training is not specific to individual subjects, so it should not go on the subject calendar.
- If the budget event does not have a set cost and the cost will vary from subject to subject, it may be easier to set this up as a variable Protocol Related Event with a $0 cost and CRA Console Trigger. This would allow the clinical coordinator to enter as a Financial Event along with the subject ID and actual cost in the comments field. The Budget Team would see those comments and update the invoice with the cost and subject ID (if needed). Ex: Patient Meals
