Subject Disposition Section
ICH E3 includes subject disposition within the clinical study report so readers can account for participants who entered, completed, discontinued, or were excluded from relevant analyses. This is CSR-specific reporting. Do not duplicate a general participant-flow page verbatim, and use the terminology and population definitions specified by the study/reporting framework.
A Subject Disposition section accounts for study participants across enrollment, treatment/follow-up, completion, discontinuation, and analysis-relevant exclusions.
Key details
Important caveats
Scope Boundary
This is CSR-specific reporting. Do not duplicate a general participant-flow page verbatim, and use the terminology and population definitions specified by the study/reporting framework.
Further guidance
Content
Report the counts and major reasons needed to trace the analyzed population from entry through completion or discontinuation, using the structure expected by the applicable CSR standard.
Purpose
A Subject Disposition section accounts for study participants across enrollment, treatment/follow-up, completion, discontinuation, and analysis-relevant exclusions.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- E3 Structure and Content of Clinical Study Reports (opens in a new tab)U.S. Food and Drug Administration · FDA-hosted ICH E3 guidance defining the structure and content of a core clinical study report