Assigning kits

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.

How to assign a kit

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.

Result of assigning a kit code

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.

Failed kit assignment at randomisation

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.

Subject without assigned kit

Subject without kit assigned at randomisation

Notifications

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.

Viewing assigned kits

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.

Randomisation with assigned kits

Subject with kit assigned after randomisation

Deallocated kits

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.

Randomisation with deallocated kit

Subject with deallocated kit

Page updated 6 Sep 2016 14:33