Clinical Studio is capable of randomizing study subjects in any way needed.
Study builders can do the following:
- Define multiple randomizations (most studies only need one)
- Import randomization schema files (usually provided by study sponsor)
- Trigger randomization from any visit or form
- Base each randomization on any number of stratifications
- Enforce form logic based on where a subject is randomized
- Randomize by site or across the entire study
- Blind or Un-blind sites to the subjects' randomization group
- Randomization - Confirmation Email Distribution List set up notices when new subjects are randomized
- Define user permissions for accessing randomization information
- View and decode the randomization allocations
The ability to define and upload randomization schemas is a permission tied to study configuration. Any user with access to the study configuration will have access to setting up randomizations as described below.
The ability to view subject randomization allocations is a permission granted in role security and is only recommended for Study Administrators or Data Managers.
Setting up randomization for a study involves 3 parts:
- Ensure randomization functionality is enabled
- Define a randomization
- Upload the randomization scheme