ECEndOfTrial object
End of trial Declaration mandatory
Yes
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
Standard Declaration form available
Yes
Standard Declaration form
A standard notification form and cover letter sample are posted on the Ministry’s website.
Guidance on End of trial declaration available
Yes
Guidance on End of trial declaration
A comprehensive guideline providing detailed guidance on format, content and required appendixes of application as well as on the trial conduct (notification on amendments, trial termination etc.) is available (Guidance on The Format of Applications for Clinical Trials to Ethics Committee 2014).
National legal framework in place
Yes
Applicable national legal framework/ Reference
Regulation on Clinical Trials of Medicinal and Biological Products 2014
Additional Information
Premature termination: a description of measures to maintain treatment of subjects already enrolled in the study, shall be submitted to the Agency and the ethics committee
