Please note: The material in this page is intended to: 1) describe OHSU's model of support and OCTRI operations, and 2) supplement the help material integrated into REDCap itself. If you are interested in learning more about a specific this feature, check REDCap for a video, check the REDCap FAQ, and review the documentation in REDCap.


Description

Implement a defined randomization model within your project and randomize your subjects. The component supports simple, block, and stratified randomization techniques, as well as open randomization and blinded randomizations.

Feature Type

Elective optional module available on every project.

Fees

No charges for use or for basic help via drop-in and email.

Eligible Projects/Project Status Dependency

    • Project Status at Setup = Development
    • Support Track = Standard Service for Research

Permissible but not recommended
Setting up randomization after a project has been moved to production and started data collection is permissible, but not recommended. It is high impact change that requires custom support for set up and testing, and for which there would be charges ($).

Request Process

  • Does not need to be requested.
  • Elective functionality that is available for use, out of the box, on every project.

REDCap Skills, Experience, Knowledge

  • Advanced syntax for variable names.
  • For longitudinal projects, advanced syntax for unique event names.

Installation, Configuration and Implementation

User Permissions

User will need permission enabled for the Project Design & Setup user right to enable the module.

magnifying glass tilted right Find: Randomization

  • To enable the Randomization module, access Project Setup tab > Enable optional modules and customizations > Randomization Module


  • Once enable, users with randomization permissions can access the module via Lefthand Nav Menu > Applications Section > Randomization.

Consultation Required

OCTRI requires that study teams using REDCap's randomization module consult with OCTRI's Biostatistics, Epidemiology, and Research Design (BERD) for assistance with defining and implementing the model your study will use for randomization and creating allocation files/tables. There are no charges for this consult.

Help and Support

Email and drop-in help are available for setting up or trouble shooting Randomization.

Set Up Notes

Assigning Users Permission to Randomization Module Once its Enabled

  • To set up randomization model
    • A user will need Randomization > Setup permissions
  • To monitor randomization activities
    • A user will need Randomization > Dashboard permissions
  • To randomize subjects
    • A user will need Randomization > Randomize permissions

Field for Capturing Randomized Assignment

  • This is the field where the allocated randomization (treatment) assignment will be saved and stored, and is where the Randomize button will appear on the a REDCap data collection form.
  • For open randomization, the field type needs be a radio button or drop-down.
  • For blinded randomization, the field type needs to be a text input.

Triggering Randomization

  • By default, randomizing a participant requires manual intervention by study staff.
    • A user with "Randomize" user permissions must click the "Randomize" button on the data entry form where the randomization field is located.
  • This is the best practice as it reduces the risk of errors in randomization participants.

Optional Configurations

  • Multiple randomizations
    • A project can set up more than one randomization model.
  • Real-Time Trigger
    • Randomization can be automated to occur in real time when an instrument is saved and a specified logic expression becomes true.
    • This is only recommended when the project required randomization to be triggered upon a participant completing a survey.
    • Automating randomization introduces a higher risk of error in randomizing participants

Support Track Availability

Standard Service for Research

This is elective functionality that is available, out of the box, on every project and that can be set up by a project builder to meet study specific requirements through self-directed instruction and in consultation with OCTRI's Biostatistics, Epidemiology, and Research Design (BERD) program. 

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