CAEndOfTrial object
End of trial declaration mandatory for
All clinical trials requiring notification to CA (without approval process)
All clinical investigations requiring authorisation by CA
Responsible for End of trial declaration
Sponsor
Legal representative domiciled in the EU/EEA
Regular Termination - Declaration timespan (max nr days)
No timeline specified in national law
Early/premature Termination - Declaration timespan (max nr days)
No timeline specified in national law
Standard Declaration form available
Yes
Standard Declaration form
F I207 ENG Beendigung Studie MP Leistungsbewertungspruefung (en/de):
Bilingual global end notification form for clinical investigations/performance evaluations
Guidance on End of trial declaration available
Yes
Guidance on End of trial declaration
ENGLISH: L I99 Guidance Document for Clinical Investigations with Medical Devices (en)
GERMAN: I192 Leitfaden für klinische Prüfung mit Medizinprodukten (de)
National legal framework in place
Yes
