ECEndOfTrial object

End of trial Declaration mandatory

Yes

Responsible for End of trial Declaration

Sponsor

Regular Termination - Declaration timespan (max nr days)

30

Early/premature Termination - Declaration timespan (max nr days)

30

Reasons for early termination shall be clearly stated

Yes

Applicable national legal framework/ Reference

Section 19 of Act No 268/2014 on Medical Devices

Feedback