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Subject flags described
In IRT, a subject can be flagged (marked) for these reasons:
- Mis-randomized—The subject was given the incorrect drugs.
A mis-randomized subject is identified with an icon (
) in the list of subjects. - Off-treatment—The subject is still being followed in the study but has been flagged for one of a variety of reasons.
An off-treatment subject is identified with an icon (
) in the list of subjects.
If a subject is incorrectly flagged, you can remove the flag. As a result, you no longer see the flag in subject lists, and the final report is adjusted so that:
- The subject counts toward the maximum number of subjects permitted in the study (study limits).
- The subject is no longer marked as mis-randomized or off-treatment in subject lists or the final report.
You must have appropriate permissions in IRT to flag a subject.
When you flag a subject, IRT prompts you to:
- Provide your password to IRT.
- Identify the reason the subject does not meet the requirements.
- Indicate whether the subject should be included in the population stud limits—that is, the maximum number of subjects that can be included in the study.
When you add or remove a flag, IRT sends you an email confirmation as a record of the information you entered.
