CAEndOfTrial object

End of trial declaration mandatory for

All clinical investigations requiring authorisation by CA

Responsible for End of trial declaration

Legal representative domiciled in the EU/EEA

Reasons for early termination shall be clearly stated


Standard Declaration form available


Standard Declaration form

Declaration of the end of the trial form (en) / Meldeformular für die Beendigung der Klinischen Prüfung (de)

Guidance on End of trial declaration available


Guidance on End of trial declaration

L I206 Leitfaden KP Einreichung (de) / L I209 Guidance CT submission (en)

National legal framework in place


Applicable national legal framework/ Reference

Art 32(1) AMG

Additional Information

Alternative declaration: Informal communication of the National End of Trial in addition to the subsequent reporting of the global End of Trial: In this case, the procedure is closed with the National End of Trial and only the provisions for the final study report remain.