Unblinding (code-break)

Opening a code-break envelope For some double-blind trials the option to unblind treatment may be offered. This option allows those authorised to unblind the treatment for a subject when it is felt necessary to do so on clinical grounds. Authorised users are administrators and 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 subjects/randomisations list, then the Unblind link in the subject details section should be clicked.

The unblinding form will request the name and email address, mobile or fax number of the person to be unblinded.

Unblinding a designated person

Unblinding a designated person

The user will then be asked to enter a reason for unblinding and their password to confirm the need for unblinding.

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, text message or fax 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, user who performed the unblinding and the designated person who was unblinded will be recorded in the details for the randomisation concerned.

The format of blinded and unblinded notifications can be viewed on the specification page.

After unblinding

When a subject has been unblinded this will be indicated by an icon in the subject listing, and the subject details will include summary information.

An unblinded subject record

An unblinded subject record

Page updated 8 Jun 2021