Clinical Study Report Title Page
ICH E3 specifies a dedicated title page for the core clinical study report and lists study-identifying, sponsor, protocol, development-phase, and report-date information to include. This is an ICH E3 clinical-study-report convention, not a universal title-page template for every research document.
The Clinical Study Report title page identifies the study and report with the core administrative details ICH E3 expects reviewers to see first.
Key details
Important caveats
Scope Boundary
This is an ICH E3 clinical-study-report convention, not a universal title-page template for every research document.
Further guidance
Content
Include the study title, investigational product, indication, brief design description when needed, sponsor, protocol identifier, development phase, study dates, responsible parties/signatures as applicable, and report date.
Purpose
The Clinical Study Report title page identifies the study and report with the core administrative details ICH E3 expects reviewers to see first.
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