New EMA document for sponsors on CTIS

The European Medicines Agency (EMA) has published a new document on the Clinical Trials Information System (CTIS). The document is aimed at sponsors of clinical trials that will be assessed in accordance with the Clinical Trial Regulation (CTR) as of 31 January 2022.

The document outlines key principles and considerations when deciding on user access, roles and responsibilities in CTIS. It also describes examples of sponsor organisation models for different kinds of clinical trials, and how sponsors can make best use of CTIS.

Sponsors are invited to give feedback on the document by completing a survey. The survey will close Friday 17 December 2021 17:00 CET.