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What blinding hides, and from whom

In blinded studies, only unblinded roles see treatment arms, block sizes, the randomization list and the unblinded kit list. Everyone else sees "Treatment assignment blinded", kit numbers without arms, and totals instead of per-arm counts.

Who sees treatment arms

Blinded rolesUnblinded roles
RolesMost roles, including the Study Owner, investigators, coordinators, CRAs, data managers and sponsorsUnblinded Administrator, Unblinded Statistician, Medical Monitor, Depot Manager
Participant page"Treatment assignment blinded" plus the randomization numberThe arm and its code, and the block
InventoryKit numbers only, supply totalsArm column, per-arm supply, the unblinded kit list
Exports and audit trailNo arm columns; arm-revealing audit details are maskedUnblinded exports with a justification and password

In open-label studies everyone sees the arm, marked Open label, and the Casebook can be filtered by arm. Arm-specific visit schedules can reveal the arm to anyone who sees the schedule, so plan them carefully (arm-specific visits).

Change the blinding level

The level (open label, single blind or double blind) is set in Settings > General > Blinding. Once participants are randomized, an open-label study cannot become blinded. Changing a blinded study to open-label needs a reason and your electronic signature, and everyone can then see the arms. In an emergency, investigators can unblind a single participant.

Questions

Is blinding only hidden in the screens?

No. Blinded roles never receive treatment arm values at all, so they cannot appear in their downloads either. Read more about blinding.

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