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University of Chicago | Center for Research Informatics | REDCap Randomization Module
REDCap Randomization Module
Randomization is a process that assigns participants/subjects by chance (rather than by choice) into
specific groups, typically for clinical research and clinical trials. Example: each subject assigned to
receive either the new treatment or the control (placebo) treatment.
The randomization module in REDCap will help you implement a defined randomization model within
your project, allowing you to randomize your subjects (i.e. records in your project). In this module, you
first define the randomization model with various parameters. Based on the defined parameters, the
module creates a template allocation table, which you can use to structure the randomization table
you will import. The module also monitors the overall allocation progress and assignment of
randomized subjects.
REDCap Helps you implement a defined randomization model within your REDCap project, by allowing
you to
1. Define all of the randomization parameters;
2. Create and upload your custom randomization table (ie, allocation list)
Table serves as a lookup table for deciding how to randomize subjects/records
REDCap DOES NOT create the randomization table for you. This table must be generated outside of
REDCap using other software (e.g. SAS, Stata, R), most likely by the statistician/data analyst involved in
your project.
By letting you create your own allocation table outside of REDCap, it lets you and your team choose
exactly how you wish to structure your allocations and assignments. Examples: block sizes,
permutations, and stratification balancing
Goals of Randomization:
To produce groups that are comparable (ie, balanced) with respect to known or unknown risk
factors.
To remove bias (selection bias and accidental bias).
To guarantee the validity of statistical tests.
To balance treatment groups, stratification factors, or both.
When to randomize?
After determining eligibility
As close to treatment time as possible (to avoid death or withdrawal before treatment start).
User Privileges
User privileges can be set to allow only certain users to be able to set up the randomization, perform
the randomization, or view the allocation dashboard to view progress. If someone is given 'Randomize'
privileges, they will be able to view and modify any existing data already collected for the
randomization strata fields (if stratification is used) when they are performing the randomization, even
if they do not specifically have form-level rights to view the form on which a strata field exists. Thus
Randomize rights trumps form-level rights in this way, but only for the randomization strata fields.