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

Table of contents

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)


How useful was this page?

Add your rating
1 rating
1 rating