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

No

Applicable national legal framework/ Reference

Art 9(c) modified RGD 30 May 2005

Additional Information

The Clinical / Final study report + publications if any have to be sent to the EC

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