To use the randomiser, it is necessary to define the parameters that are used to define how stratification is performed. For all studies sex and centre will be presented as possible stratification parameters. Additionally, any custom fields defined for the participant register (see the section called “Participant Register”) will be shown. At least one stratification parameter must be chosen.

To use the randomiser, it is necessary to define the treatment arms that can be assigned. At least two treatment arms must be set. A name and a code for each treatment arm must be set (e.g. Treatment Name: Cognitive Behavioural Therapy, Treatment Code: CBT)

Minimum and maximum block sizes must be set for the randomiser. Block sizes must be a mulitple of the number of treatments, and the maximum block size cannot be less than the minimum block size.

Notification of randomisation decisions can be sent by email to users with the relevant roles. To set which roles receive which email notifications, use the check boxes.

Notification of RS Decision: This will send an email when the treatment arm has been assigned. It will contain the participant but not the treatment arm.

Notification of RS Invocation: This will send an email when the randomisation process has begun for a particular study number.

Notification of RS Treatment: This will send an email containing the study number and the treatment arm to which the participant has been assigned.

In addition to the randomisation settings required here, it is also necessary to specifiy a document that will trigger the randomisation event. You must select a document from the available list. When the document is completed, the user will be prompted to randomise this participant.