...
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?
...