CAEndOfTrial object
End of trial declaration mandatory for
All clinical trials requiring authorisation by CA
Responsible for End of trial declaration
Sponsor
Regular Termination - Declaration timespan (max nr days)
90
Early/premature Termination - Declaration timespan (max nr days)
15
Reasons for early termination shall be clearly stated
Yes
Guidance on End of trial declaration
The procedure for End of Trial notification follows the EU Commission’s CT-1 and CT-3 guidance.
Detailed information on performing national submission for Ireland is provided in the HPRA Guide to Clinical Trial Applications, which is available on the HPRA website in section: Medicines>Regulatory Information>Clinical trials>Clinical Trial Applications
Additional Information
Note: If the trial ends in Ireland before the trial has ended globally, it is recommended that the sponsor notifies the HPRA in writing as justification for no longer submitting amendments or DSURs.