Unblinding (code-break)
For some double-blind trials, the option to unblind treatment may be offered. This option allows those authorised to unblind the treatment for a participant when it is felt necessary to do so on clinical grounds. Authorised users are those with an unblinding account. For some trials, investigators may also be allowed to perform unblinding.
To unblind a randomisation, the record should be viewed by clicking in the participants/randomisations list, then the Unblind link in the participant details section should be selected.
There are different types of unblinding (i.e. screen, email, screen and email, and third-party unblinding), which determine how the true treatment group information will be revealed. The type of unblinding configured for your trial can be viewed on the specification page.
Screen and/or email unblinding
If your system has been configured to have screen, email, or screen and email unblinding, the logged-in user will have to enter the reason for unblinding and their password on the unblinding form. Subsequently, the true treatment allocation will be shown on screen, will be emailed to their registered email address, or both, depending on the type of unblinding.
Logged-in user enters reason for unblinding and their password for screen unblinding
In screen unblinding, the treatment group is shown to the logged-in user on screen
Third-party unblinding
If your system has been configured to have third-party unblinding, the unblinding form will request the name, email address and/or mobile number of the person to be unblinded, as well as the reason for unblinding and the password of the logged-in user.
Unblinding a third party
After entering these details and clicking the 'unblind' button, the user will not be shown the true treatment allocation on screen. Instead an unblinded email and/or text message will be sent to the designated person. An email stating that an unblinding has taken place will be automatically sent out to all trial administrators and all investigators associated with the site that the randomisation originates from, as long as they have notifications enabled. The date and time of unblinding, the user who performed the unblinding and the designated person who was unblinded will be recorded for the randomisation concerned.
The format of blinded and unblinded notifications can be viewed on the specification page.
After unblinding
When a participant has been unblinded, this will be indicated by an icon in the participant listing, and the participant details will include links to all unblinding events.
An unblinded participant record with link to previous unblinding