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

Heading

Required Items

Recommended Items

Optional Items

Objectives

Background to objectives

 

Power/Sample Size Calculation

 

Statistical Analysis

 

Hypotheses

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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