ECEndOfTrial object
End of trial Declaration mandatory
Yes
Responsible for End of trial Declaration
Sponsor
Legal representative domiciled in the respective country
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.
National legal framework in place
Yes
Additional Information
If the clinical trial was terminated early, its grounds will be stated and an information letter regarding the measures for maintenance of the treatment of the volunteers enrolled into the study will be attached.
In cases where early termination was due to safety reasons, the Agency shall inform the situation to the European Union Commission through the agency of the Ministry of Economy or electronically.