Drug database
CTIS - Handbook for Sponsor
Important information for sponsors of clinical trials of medicinal products for human use in the context of the EU portal (CTIS).
At the end of July, the EMA team published the first version of the CTIS Guide for Sponsors, that provides guidance for sponsors on how to use CTIS, including links to other materials. The guide is aimed at pharmaceutical companies, CROs, small businesses and academic sponsors. The handbook can be found on EMA website.
August 8, 2021
Department of Clinical Trials on Pharmaceuticals