How to: Add Randomization Module in REDCap

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How to: Add Randomization Module in REDCap

Unread post by shipy » March 10th, 2021, 11:16 am

What is Randomization?
Randomization is a process that assigns participants/subjects by chance (rather than by choice) into specific groups, typically for clinical research and clinical trials. 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.

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.
How do I Enable Randomization?
1. Ensure you have the "Project and Design" privileges. This will allow you to view the Project Setup page. Otherwise, enable this setting in the "User Rights" link in the left-hand menu. If you do not see User Rights, please ask your project manager to give the appropriate permissions.
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2. Go to the "Project Setup" page and scroll down to see the "Enable optional modules and customizations". Enable "Randomization module".
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3. For the next example, we will use REDCap's template to show a Randomization example. Create a New Project and select the Template in the lower screen for Project creation options.
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4. Click "Randomization" on the left-hand menu to view the Setup area. You will see that Step 1A) is to choose the strata or criteria which will allow REDCap to assign the record to a "randomized" slot/study. This example asks for "Race" and "Gender" to be inputted within REDCap.
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5. In Step 1C), we are asking REDCap to create a Randomize button and assignment slot in an existing field called "randomization_group (Randomization Group)".

6. In Step 2, we will simply download one of their examples.
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Please note that Example # 2 provided by REDCap will not upload properly due to hidden values in the first row. Here is the cleaned-up version where we delete the empty cells to the right of the existing CSV.
(3.04 KiB) Downloaded 29 times

7. Upload your allocation table in Step 3.
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Note: It is highly recommended to pair with a statistician to create and test the table with you.
Ensure that you are in Development Mode (testing) to input any test data and randomize some records.
See our topic on How to Test your project thoroughly:

Randomize Example:
E1. Going into the VCU Project Template, we can "Create a New Record" (Add/Edit Records), and view the instrument "Demographics". We will choose "American Indian" and "Male" and Save Record.
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E2. Go to the "Randomization Form" instrument to click "Randomize". We know that the first record will be randomized/assigned to Drug A since REDCap will take the first matching case in descending order.
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The next American Indian Male to be randomized will get Drug B and the next American Indian Male to be randomized will get Drug C according to our Allocation table.
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8. To verify your results and allocations, you may take a look at the "Randomization", Dashboard.
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9. When you are ready to move into Production, go back to Randomization Step 3 and upload an allocation table for the Production instance if the table differs from the Development instance. If the Development table is the same, delete the Development table which would also delete all existing allocations, then upload the Production version.
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Any questions or suggestions, please "Post Reply" below!
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