Double blind trials use a code list to automatically assign kit codes at randomisation. Kits can also be assigned at a later time by administrators or investigators, at follow-up visits, for instance, or to replace lost or damaged kits.
Not all trials with a code list can assign kits. This feature will not be available in trials where the drug is made up in the pharmacy on demand using bulk supplies.
To assign a new kit to a randomised subject, first locate the subject in the randomisations or subjects list. A link to assign a kit code is shown. This takes the user to a form to complete with the reason for assigning a new kit. Depending on the trial, this form may also have options for selecting visit, kit type or number of kits required. The user must enter their password to confirm the action and a new kit code(s) will be chosen from the code list and shown to the user.
Screen showing result of assigning a new kit code
The kit is chosen according to a dispensing policy in the same way as at randomisation. If insufficient kits are available an error message will be shown when trying to assign a kit.
Occasionally, if a subject is randomised at a site with low stock levels, a suitable kit may not be available that matches the chosen treatment group. In this case the subject will be shown with a warning message that no kits have been allocated. A kit should be manually assigned as soon as the site is re-supplied. This situation can be prevented by turning on the Ensure all groups available at site setting.
Subject without kit assigned at randomisation
An email notification will be sent out to the same recipients as for randomisations. The format of the email can be seen on the specification page.
Assigned kits are shown in the kit codes section of the randomisation or subject details. All kits assigned are shown in the Kit codes column of the randomisations or subjects list. The list can be searched to find the subject a specific code was assigned to.
Subject with kit assigned after randomisation
If a kit has been deallocated from a subject in the code list, it is still shown in the assigned kits section along with the date of deallocation.
Subject with deallocated kit