Export treatment arms (unblinded data)
Unblinded users tick Include treatment arm assignments (unblinded) on the export, choose a justification such as Interim Analysis or DSMB Request, and confirm with their password. Blinded users never see the option, and every unblinded export is logged.
Before you start
- You hold an unblinded role (for example Unblinded Statistician, Unblinded Administrator or Medical Monitor). In open-label studies anyone who can export sees the arm option.
Include treatment arms
Set up your export in Data & Exports > Export Data.
Under Blinding Options, tick Include treatment arm assignments (unblinded).
Choose a Justification: Interim Analysis, DSMB Request, Regulatory Submission, Database Lock, Safety Review, Study Close-out or Other.
Click Continue to Verification, enter your Password and click Confirm & Proceed.
Download the export.
The export log marks it Unblinded, and the access is also recorded in the audit trail.
Coded arm labels
If the study uses coded arm labels, exports show labels such as "Group A" instead of the arm names. Download code key gives the label-to-arm key, behind the same justification and password check. Coded labels are set up in Settings > Randomization > Coded arm labels.
Restrict all exports to unblinded roles
The Unblinded Administrator can switch on Restrict exports to unblinded roles in Settings > Randomization > Export Restriction. Everyone else then sees "Export restricted" on Data & Exports. Read more about blinding.
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Please never send participant names, contact details or health information to support.