Clinical Trials Regulation - Version 6.9 of the Q&As

The European Commission (EC) has published an updated Version 6.9 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR).  

The following Q&s have been revised / added:

• Revised Q&As 2.9 (regarding the publication of the assessment report on part I and II) and 6.5 (on the CTIS publication rules) in line with the revised CTIS transparency rules. 
• Revised Q&A 3.13 on the change of the principal investigator
• Revised Q&A 6.1 (on endpoints to be summarized in the summary of results) including reference to paediatric clinical trial results
• New Q&A 6.6 on intermediate data analysis
• Annex II (Language requirements for part I documents): Footnote 2 (patient facing documents) also applies to Estonia (to be submitted at least in the official national language(s) of the region(s) where the trial is conducted. EN is optional)
• Annex III (Part II documentation - where sponsors can find national requirements): Hungary: New Email address for enquiries related to Part I clinical trial applications; Finland: new national websites; Romania: New Email address for enquiries related to Part II clinical trial applications
• Annex IV (Classification of changes to ongoing clinical trials): Extension of validity decision as substantial modification for part I+II or part II only
• Annex V (Changes to source country): Deletion of Summary of product characteristics (SmPC) requirement for authorized AxMPs 

More information is available in the CLINICAL TRIALS REGULATION (EU) NO 536/2014 - QUESTIONS & ANSWERS VERSION 6.9 available in EudraLex - Volume 10 - Clinical trials guidelines.