CAEndOfTrial object
End of trial declaration mandatory for
All clinical investigations requiring authorisation by CA
Responsible for End of trial declaration
Sponsor
Legal representative domiciled in the EU/EEA
Reasons for early termination shall be clearly stated
Yes
Standard Declaration form available
Yes
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
Yes
Guidance on End of trial declaration
L I206 Leitfaden KP Einreichung (de) / L I209 Guidance CT submission (en)
National legal framework in place
Yes
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.
