CAEndOfTrial object

End of trial declaration mandatory for

All clinical trials requiring authorisation by CA

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 declaration of the end of a clinical trial should be sent to MHRA within 90 days of the global end of the trial.

European Standard Declaration Form (Eudralex Volume 10) to be used.
End of trial declarations shall be submitted via CESP.

Guidance on End of trial declaration available

Yes

Guidance on End of trial declaration

"Clinical trials for medicines: manage your authorisation, report safety issues - Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report"

National legal framework in place

Yes

Applicable national legal framework/ Reference

Part 3, section 27 and Schedule 3, Part 4 of the Medicines for Human Use (Clinical Trials) Regulations 2004

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