Clinical Study Report Introduction Section
ICH E3 section 7 calls for a brief introduction that places the study in the development context of the investigational product and relates key study features to that context. This is narrower than a general academic introduction: it serves the ICH E3 regulatory study-report function and should not be expanded into a literature review by default.
The CSR introduction briefly explains where the study fits in the product’s development program and why its main design features matter in that context.
Key details
Important caveats
Scope Boundary
This is narrower than a general academic introduction: it serves the ICH E3 regulatory study-report function and should not be expanded into a literature review by default.
Further guidance
Content
Keep the introduction brief; identify the rationale and aims, target population, treatment, duration, primary endpoints, and relevant guidelines or sponsor–authority agreements when applicable.
Purpose
The CSR introduction briefly explains where the study fits in the product’s development program and why its main design features matter in that context.
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