Randomization is a study design that randomly assigns participants into an experimental group or a control group.
As the study is conducted, the only expected difference between the control and experimental groups in a randomized controlled trial (RCT) is the outcome variable being studied.
• Types of randomized trials/studies
1. Unblinded
2. Single blind
3. Double blind
• The Randomization Module can be very useful when
A. Using a qualified biostatistician to create the allocation tables
2. Accompanied by a documented process for
A. Randomization procedure
B. Unblinding procedure for blinded studies
• Define the randomization model with various parameters from the project
• Based on the defined parameters, the module creates a template allocation table which can be used to structure your allocation tables you will import
• The module also monitors the overall allocation progress and assignment of randomized subjects
• User privileges can be set to allow users
1. Set up randomization
2. Perform randomization
3. View allocation dashboard
• Someone with randomize privileges will be able to view and modify existing data used for stratification even if they do not have Forms privileges
• Once you select this option you will be able to see how the rest of the process occurs
• The BMIC can assist you and your biostatistician with this process
1. Allocation tables can be extended but it is not a great idea - create enough size to handle the trial
2. The integrity of any RCT is dependent on everything having SOPs, especially randomization!