Randomization and Treatment Assignment

Here are the required and recommended information to be reported about a trial's treatment assignment. The bolded items are part of the Minimal Data Set.

Click on Descriptor Name for an example of the item.


Treatment Assignment

Heading

Required Items

Recommended Items

Optional Items

Randomization

 

Allocation Concealment

Methods used to implement the allocation sequence

 

 

Assignment

Who assigned participants to their groups

Delay between enrollment and assignment

Who generated the allocation sequence

Randomization Efficacy

Number of participants in each intervention group

Statistical test of differences between subgroup characteristics

Statistical test of differences between intervention group characteristics

Assignment Blinding Efficacy

 

 

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