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Transactions that could require approval
During the design phase of the study, the sponsor decides which transactions require approval and how many levels of approval are required. These transactions can include:
- A rollback of subject information from a randomization or later visit to the previous visit.
Rollbacks return the subject information to an earlier state, and can also remove an early termination, screen failure, or subject completion that was made in error.
- Edits to subject data collected during a visit, such as demographics or the date of the visit.
- Reallocation of drug units that were identified by IRT but were not provided to the subject.
- Out-of-window requests—that is, visits that are required to be completed either earlier or later than the original date on the visit schedule.
- Out-of-range approvals for subjects who do not meet the age requirements of the study. These requests are automatically sent to the approver based on the birth date entered during a screening visit.
