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The process of approving the drug and randomization schedules
During the study setup:
- A Statistician reviews and approves the randomization schedule.
The randomization schedule lists the randomization numbers and the associated treatment groups to which subjects can be assigned. The randomization schedule must be approved before any subjects can be randomized into the study.
- An unblinded user, typically the Drug Supply Manager, reviews and approves the drug schedule.
The drug schedule lists each drug unit that can be used in the study. Before the drug schedule is approved, records are not available for any drug order. After the drug schedule is approved, drug units can be associated with depots, assigned lot numbers, added to label groups, and shipped to sites.
