Inclusion of appendices to clinical study reports in marketing authorisation applications - Scientific guideline

This document clarifies which appendices to clinical study reports should be systematically included in marketing authorisation applications and which may be available on request of the competent authorities.

Keywords: Clinical study report, initial application dossier, study information, protocol, patient data listing, adverse event, case report form (CRF)

Current effective version

Note for guidance on the inclusion of appendices to clinical study reports in marketing authorisation applications

Adopted Reference Number: CHMP/EWP/2998/03 Final Legal effective date: 01/12/2004