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Mis-randomized subjects
A subject might be identified flagged as mis-randomized if the subject was randomized but:
- Was not actually eligible for randomization.
- Invalid stratification factors were entered.
Mis-randomized subjects are marked with an icon (
) in the subject list and are documented in the final report for the study.
You must have appropriate permissions in IRT to perform this task.
You might need to perform additional tasks after flagging the subject. For example, if the subject should continue in the study, you might need to:
- Roll back the visit
- Reallocate the drug units
