Randomisation involves multiple subjects being 'stratified' into different groups, each subject receiving a treatment allocated from a predefined random sequence for that particular stratification group. Click to see the types of randomisation supported by ALEA.
For example, you may want to randomise subjects based on a calculated risk category, which may be one of three values such as low, intermediate and high. A subject is then allocated a treatment from one of three predefined random sequences of treatments, one for each risk category. So when a subject is assigned to a risk category, they are given the next available treatment from the random sequence for that risk category. This prevents, for example, all low risk patients accidentally being assigned the same treatment.
MACRO works with the TENALEA hosted randomisation service, provided by FormsVision BV in The Netherlands and based on the ALEA® software suite.
Some manual setup is required in both MACRO and ALEA.
In MACRO, the randomisation feature works in conjunction with subject registration. Once randomisation is set up, both are triggered at the same time and registration is carried out via the ALEA server instead of in the usual way. A derived question can be created to display the returned registration subject identifier if required.