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Randomized Clinical TrialPID 7
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. Note: It is recommended that only people with experience in randomization set up the Randomization module. More details

STEP 1: Define your randomization model

This step will allow you to define the randomization model you will be implementing and all its parameters, which includes defining strata (if applicable) and optionally randomizing subjects per group/site (if a multi-site study).

NOTE: This section is currently locked and uneditable because the randomization setup process has already been completed.  Because this project is in Production status, the randomization setup values below CANNOT be modified.

A) Use stratified randomization?  
It is often necessary to ensure equal treatment among a number of factors. Stratified randomization is the solution to achieve balance within one or more subgroups, such as gender, race, diabetics/non-diabetics, etc. By choosing strata (multiple choice criteria fields), you may then be able to ensure balance within those subgroups. Tell me more
Choose strata (criteria fields used for stratification; may specify up to 14 multiple choice fields)
B) Randomize by group/site?  
If this is a multi-center/multi-site project (or something similar), you may want to stratify the randomization by each group/site. You can select an existing multiple choice field that represents the groups/sites, OR you can use Data Access Groups to stratify by group/site.
C) Choose your randomization field
This is the field where the allocated randomization (treatment) group will be saved and stored, and is where the Randomize button will appear on your data collection form.
  

STEP 2: Download template allocation tables (as Excel/CSV files)

Below are some example files that you may download to get a general idea for how you may structure your own randomization table. You do not have to use any of these. In fact, we recommend that you NOT use these exact templates but instead recommend that you merely use them as an example or baseline to start from in order to create your own custom allocation file. After uploading your allocation table in Step 3 below, it will then be used as a lookup table to perform assignments when subjects are being randomized. NOTE: Record names (e.g., study ID) should NOT be included as a column in your allocation table, but only the fields listed in the example files below. More details

   

STEP 3: Upload your allocation table (CSV file)

Once you have created your custom allocation table as a CSV file and made sure that you kept the format prescribed in the template files from Step 2 above, you may now upload the file below. It will be checked for any possible errors first before it is accepted and stored in REDCap. Please note that you will need to create two different allocation tables: one to be used for testing while your project is in development status and the other for use when in production status. Below are some important reminders before you begin uploading your allocation tables.

Reminders:
• Once your project is in production status, the allocation tables will become locked and unmodifiable.
• Be sure to include more assignments in your allocation table than you think you will need (to accommodate possible drop-out and drop-in of subjects).
• Record names (e.g., study ID) should NOT be included as a column in your allocation table, but only the fields listed in the example files from Step 2 above.
Not uploaded yet
Upload allocation table (CSV file) for use in DEVELOPMENT status
Not uploaded yet
Upload allocation table (CSV file) for use in PRODUCTION status
NOTE: If necessary, a REDCap Administrator may upload more allocations while the project is in production. When they access this page, they will see a form below to upload another allocation table. The uploaded table will NOT replace the existing allocation table but instead will ONLY APPEND to it, thus adding more allocations.
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