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Types of corrections you can configure
You can configure settings in IRT to allow users to correct subject information after it is saved. Review the approval roadmap in the User Guide before starting the configuration process.
You must have the appropriate permissions in IRT to perform these tasks.
The types of subject information you can correct are:
- Subject data edits
Subject data edits are corrections to the subject information gathered during a subject visit. These changes can include subject demographics, transaction date, and other study-specific information.
- Visit rollbacks
A rollback restores the information gathered during a visit to a previous state—typically, to the last fully correct version of data for the subject.
- Drug reallocation
Drug reallocations in unblinded studies must be acknowledged by an unblinded role.
Drugs are reallocated when drug units that have not been assigned by IRT are provided to the subject during a visit. During reallocation, you identify the drug units that were provided to the subject, and reallocate the drug units that should have been supplied to the subject.
- Missed visit approvals
When a visit is missed, the visit date is not captured, and the patient is moved to the next visit in the visit schedule. A missed visit might require an Approval.
- Out-of-window approvals
Out-of-window visits occur outside the number of days either before or after the date on the visit schedule that a visit is permitted to happen. An out-of-window visit might require approval.
- Out-of-age approvals
An out-of-age approval request is a request for a subject who does not meet the study age requirements to continue in the study.
