The EMA Clinical Trials Information System (CTIS) Sponsor Handbook provides clinical trial (CT) sponsors representing pharmaceutical industry, SME (small and medium-sized enterprises), academia, research organisations and other clinical trial sponsor organisations with the operational guidance they need to create and submit clinical trial information to the member states of the European Union/European Economic Area (EU/EEA) through the CTIS
The handbook now explicitly integrates references to the newly published Sponsor FAQs.
- The system is learning from real-world friction.Instead of scattered guidance → more centralised, usable knowledge.
- More precise instructions on how to use the “update” functionality when drafting Substantial Modifications (SM) and Non-Substantial Modifications (NSM).