Study Design

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

Click on Descriptor Name for an example of the item.

Study Design


Required Items

Recommended Items

Optional Items


Background to objectives


Power/Sample Size Calculation


Statistical Analysis



Primary hypothesis

Secondary hypothesis


A priori Subgroups

Subgroup names and definitions

Reasons for these a priori subgroups


Post hoc Subgroups



Study Monitoring

Description of monitoring personnel

How recommendations for study termination are communicated to investigators

Protocol Changes

Description of protocol changes

Reason for protocol changes

Dates of protocol changes

Why Study Stopped

Reason study stopped



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