How to Configure Strata

Randomization with stratification is used to randomize participants based on a set of criteria, like BMI, age, disease type, etc.  See Randomization for more detailed information. 

1. After choosing 'Block Randomization with Stratification' for randomization method, set up strata by going to the Manage Study drop down and clicking 'Configure Strata'.  Select 'New'. 
   
   
   
   
2. Name the strata and select the correct number of block sizes from the drop down.  You can select more than one block size. Then click 'Save'. 
   
   
3.  Repeat #2 for all strata
   
   
   
   
4. The stratification is based on a survey or office visit question.  If your study is stratifying based on 2 age groups, like the above example, then you must determine which age bucket the participant falls into via a survey question.  In this example, the age question will be asked in the Informed Consent. This could also be done via an office visit survey or in the screening survey. 
   
   To build the strata logic, navigate to the 'Informed Consent' logic in enrollment. 
   
   
   
   
5. Select the question and answer that will determine the strata.  For the 'Then' statement, select 'Add a consequence' and then 'Assign participant to a strata' and select the matching strata from the drop down. Repeat for all strata options, in this example, for the 2 age groups. 
   
   
   
6. Click 'Save Logic' at the bottom.
   
   
7. Once a participant is assigned a stratum, their stratum assignment will appear on their backend profile.  Participants cannot see this designation on the frontend dashboard.