ECEndOfTrial object
End of trial Declaration mandatory
Yes
Responsible for End of trial Declaration
Sponsor
Regular Termination - Declaration timespan (max nr days)
90
Timespan counted from
Last participant - last visit
Early/premature Termination - Declaration timespan (max nr days)
15
Reasons for early termination shall be clearly stated
Yes
Standard Declaration form
The standard Declaration of the End of a Clinical Trial form (Form 6) applies to both the normal conclusion and premature termination available on the Department of Health website in section: Policy A-Z>C>Clinical Trials Involving Medicinal Products > Application Forms
Guidance on End of trial declaration
Further details on the End of Trial obligations are provided in the Guidance booklet on applications to Recognised Ethics Committees (RECs), available on the website of the Department of Health in section: Policy A-Z>C>Clinical Trials Involving Medicinal Products.
