This article describes how to define a randomization.First, open the page "Define Randomization" from the Study menu:

After opening the page you will see existing configurations as below.  You can set roles to receive Randomization Confirmation E-Mail at this point.
Or you can follow the annotated image below for a description of each item when editing or creating a new configuration

  1. Enter a name for the randomization. Example: Gender-Based Randomization
  2. Blinding - Leaving this box unchecked will ensure the site does not see the group to which the subject was randomized.
  3. Return Subject ID - The system can optionally return a new Subject Profile ID with a new allocation. When a subject is successfully randomized, the system will pull the Subject Profile ID from the randomization schedule and overwrite the system-generated Subject Profile ID. If you want to save both the system-generated ID and the randomization ID from the schedule, see the next item below.
  4. Return Randomization ID - This will provide an option for text fields in the Form Builder to define for populating the subject's Randomization ID into a CRF. This allows for maintaining the system-generated ID as the subject ID and still have reference to the randomization ID in the subject data.
  5. Centralized - Some studies may require that the pool of randomization allocations not be site based. Most randomizations will evenly distribute arms among sites. However, in some cases you may want to remove that layer of site stratification. This will mean that when randomizing, the system will pull the allocation based on any other level of stratification (or no stratification at all).
  6. Trigger Form - Select which form the randomization will occur on.
  7. Trigger Visit - Select which visit the randomization should occur on.
  8. Field To Randomize On - Select which field(s) the randomization is based on. These need to be the same stratification fields included in the randomization scheme
  9. Save the defined randomization

Continue reading about how to setup and upload a randomization scheme.