Spring Intro 2023

24/03/2023

Clinical Trial Information System (CTIS)

9

Assessment of new application and decision

• After the application has been uploaded to CTIS, the Member States concerned will assess whether it is valid • Subsequently, two investigation reports are compiled, Part I and Part II o Part I, investigated in international cooperation for trials involving at least two EU Member States or countries that are part of the European area of cooperation o Part II is always investigated nationally • Only one decision is made per Member State

• CTIS Evalutation Timelines (CTIS Training Programme, EMA)

10

10

5