Randomization in REDCap

The REDCap Randomization Module allows you to implement a defined randomization model in your project, using an uploaded .csv file (“allocation table”) where REDCap will look up and find group assignments. The allocation table should be created by a statistician or a REDCap team member, never by a study team member.

Study team members should never see or upload the allocation tables in order to maintain concealed allocation, aka the concept of the “sealed envelope.” Concealed allocation prevents selection bias by preventing study staff from knowing which allocation will come next. This procedure is separate and apart from blinding- study staff may not be blinded to the subject’s allocation, but they still should not know which allocation to anticipate next.

The Randomization Module allows for upload of two different tables – one for Development mode and one for Production mode, to facilitate adequate testing before moving to Production.

Setting up randomization in the CHOP REDCap always requires the assistance of the REDCap admin team. See here for detailed instructions on the randomization setup process.