Stratified, Multi-Arm Randomization

Clinical Studio allows you to implement a wide array of randomizations. You can have as many randomization events per study as you wish. Randomizations can be stratified on zero or more form variables. Randomizations can be central or site stratified. A randomization can optionally return a Subject Profile ID. A randomization can happen at any time interval. For example you may randomize at enrollment, after the 30 day follow-up and again after the 5-year follow-up. All of this is defined by the Study Designer.

randomization in clinical trials
Define Randomization

Clinical Studio supports the uploading of a permuted block, multi-arm randomization file. This file is used to determine sites and subjects that are participating in a given study. The file supports multiple arms and can be coded for true randomization allocation blinding.

Once a subject is randomized, the allocation assigned to the subject can be used in any conditional action for any form. This allows fields, forms and visit intervals to be disabled or hidden based on how a given subject was randomized.

The file can be easily created using Excel. Uploading is a very easy process and sets up the parameters of the study.