The European Commission has issued new versions of the following:

Chapter I: Application and Application Form

• Substantial Amendment Notification Form (revision 3 of June 2010)
• Declaration of the End of Trial Form (revision 3 of June 2010)

Chapter V: Additional Information

• "Questions & Answers" Document - Version 6 (June 2010)

The revised documents are available on the Commission's website for Eudralex Volume 10 Clinical Trials Guidelines.