What fields should I include on my randomisation form?

If you are using our comprehensive randomisation service, we customise the randomisation form for your trial. The fields to include on this form would normally include:

• A participant identifier, e.g. pre-existing trial identifier, screening number or other way of uniquely identifying the participant (such as initials and month/year of birth). This is so that you can later match up randomisations to other participant records.
• Stratification or balancing factors (if any)
• Inclusion and exclusion criteria. Each criteria is a yes/no question such as “Is the patient aged 18-65?”, “Is the participant pregnant?” etc. We will set up the form so that the patient must be eligible by these criteria to be randomised. If you have already recorded detailed responses elsewhere, the randomisation form questions might be global checks (“Does the patient meet all inclusion criteria?” and “Does the patient meet any exclusion criteria?”). 

Note that the user who carried out the randomisation, site and date/time of randomisation are always recorded so there is no need to specify these.