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Subjects who are removed from the study
You cannot delete a subject from the study. However, you can discontinue a subject from the study before the end of the visit schedule with early termination.
When this procedure has been completed, all drug units that are resupplied for this subject are discontinued.
During early termination, you do the following:
- Verify the subjects' identity against the basic demographic information gathered during screening.
- Provide a reason the subject is being discontinued from the study.
- Provide the date you documented the early termination.
