Concomitant Medications Section
ICH E3 includes prior and concomitant therapy/medication information in the clinical study report because other treatments can affect interpretation of efficacy and safety. This reports what participants actually used; it is distinct from a protocol Concomitant Care section that prospectively states which outside treatments are permitted, restricted, or prohibited.
A Concomitant Medications section reports relevant medications or therapies used before or during the study when they matter to interpretation of study treatment, efficacy, or safety.
Key details
Important caveats
Scope Boundary
This reports what participants actually used; it is distinct from a protocol Concomitant Care section that prospectively states which outside treatments are permitted, restricted, or prohibited.
Further guidance
Content
Summarize the categories, timing, frequency, or treatment-group patterns needed for interpretation and provide detailed listings where the CSR framework requires them.
Purpose
A Concomitant Medications section reports relevant medications or therapies used before or during the study when they matter to interpretation of study treatment, efficacy, or safety.
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