We can offer you an emergency code break (unblinding) service using either an internet or automated telephone based solution. Available 24 hours a day it means investigators can break the treatment blinding when patient safety is at risk.
Investigators break the blind by simply providing the unique randomisation number, vial number or other identifier used for your trial medication or intervention. Investigators are immediately notified of the unblinded treatment allocation.
Investigators contact an intermediary (e.g. trial coordinator or on-call clinician) and request unblinding. The intermediary uses our system to enter information about the patient and reason for unblinding. The investigator is sent an email or fax with the unblinded treatment allocation. The intermediary remains blinded.
Treatment allocation can take account of patient characteristics and trial phase if necessary.
We can give you a code break homepage that you can use to give guidance on the circumstances under which unblinding may become necessary.
Trial co-ordinators can choose to be notified by email and/or fax of every new code break.
An administrative control panel shows details of all code-breaks and allows user accounts to be managed.
Users require valid authentication details to access the code break application.
Log files detailing all activity on the code break system are available to the trial co-ordinator.
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