Randomisation refers to the allocation of different treatments to subjects on a random basis. In MACRO, you can use the subject registration feature to trigger the randomisation process. Arezzo Composer enables you to set up predefined random sequences which are then used to allocate a treatment to an individual subject when they meet specific conditions.
In the simplest scenario, you can randomise subjects based purely on the next available treatment in a single sequence. The sequence number for each subject is generated by the MACRO registration process.
Before you begin to set up randomisation in MACRO, use the following points to help you decide exactly how you want it to behave.
Decide how many random sequence strings you need. In Arezzo, the maximum string length is 1000 so if you need to randomise more than 1000 subjects, you will need to create multiple sequences. Have the strings ready to enter into Arezzo.
Identify the point in the study where you want randomisation to occur.
Identify the conditions that must be met for a subject to be randomised. Ensure you have created the questions to collect this data and placed them in the appropriate eForms and visits.
Each randomised subject will be assigned a unique identifier code. Decide how you want this code to be constructed. It can be a simple number or it can be prefixed and/or suffixed by a string or an Arezzo expression or a combination of both.
Decide what you want to do with this unique identifier code. You may wish to use it as the subject label and/or you may wish to display it as a question on an eForm. Or you may simply wish to refer to it in an Arezzo expression elsewhere.
Likewise, decide what you want to do with the returned treatment result for a randomised subject. You may wish to set up a derived question to display it on an eForm or simply use it to determine which further questions are presented for the subject.
In order to set up randomisation, you will need to be comfortable creating Arezzo expressions and have a basic knowledge of Arezzo Composer.
Randomisation is set up for a single study and the settings are included as part of the study definition when you export the study.