Europe - Updated EC Guidance for the Transition of clinical trials from the CTD to the CTR (version 4)

The European Commission (EC) has released an updated version (v4.0) of its Guidance for the Transition of clinical trials from the Clinical Trials Directive to the CTR.

The updates include the following:

• Clarification of consequences of non-compliance with transition requirements
• Addition of Annex II
• Clarification on the interface with medical devices and in vitro diagnostic
• Clarification on active sites
• Minor amendments to elements related to the CTIS transparency rules
• Addition of information on EE in Annex I

This EC Guidance reflects the agreement reached by the National Contact Points and supersedes the chapter 11 of the Q&A on the application of the CTR (version 6.4).

Reference document: EC Guidance for the Transition of clinical trials from the CTD to the CTR (version 4).pdf