ECEndOfTrial object

End of trial Declaration mandatory

Yes

Responsible for End of trial Declaration

Sponsor
Investigator

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

End of trial notification to the relevant EC shall be made by use of the form provided in Appendix 4 to Decree No. 841/2010: “Notification of termination of a clinical drug trial”.
NB: Appendices are not available in English!

Applicable national legal framework/ Reference

Section 10h of Act No. 488/1999

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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