Disposition Phases Hierarchy

Hierarchy Check

Introduction 

Every clinical trial has several phases throughout the trial. Participants may withdraw during the study at various stages for a variety of reasons.  Therefore, it's crucial to keep track of the number of participants, or "N," at each stage.

Purpose

Validates the consistency of the N in each phase, comparing two by two, each time a phase with the one preceding it, by checking that the participant count in each phase is equal to or greater than that of the following phases, maintaining the integrity and progression of the study

Applicability 

Inclusion conditions 

• Drug studies only 
• Source data should contain the term ‘adds’ only
• Detection of more than one trial phase
• Detection of a row that indicate the N in each phase, 
• Key-phrases
  • ‘participants started/assigned to treatment’  
  • ‘participants entered’
  • ‘subjects started/assigned to treatment’   
  • ‘subjects entered’  

Exclusion 

• Empty table
• Vaccine studies

Discrepancies

• The number of participants in an earlier phase is less than the number of participants in a later phase

Discrepancy Example

Number of participants in the screening phase is less than the number of participants in the treatment phase.