Clinical study report
A clinical study report is a report on the clinical trial presented in an easily searchable format, prepared in accordance with Annex I, Part I, Module 5 of Directive 2001/83/EC and accompanying an application for marketing authorisation. See also ICH guideline E3 on structure and content of clinical study reports.
In cases where the clinical trial was intended to be used for obtaining a marketing authorisation for the investigational medicinal product, a clinical study report should be submitted to CTIS by the applicant for marketing authorisation within 30 days after the day the marketing authorisation has been granted, the procedure for granting the marketing authorisation has been completed, or the applicant for marketing authorisation has withdrawn the application.