Termination of study

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3.12 Termination of Study

The protocol should define the end of study. The Data Monitoring Committee (DMC) [or Data Safety Monitoring Board] (DSMB)] have access to the unblinded results at prespecified points in the trial. They have the responsibility for deciding whether, while randomisation is in progress, the unblinded results should be revealed to the Trial Steering Committee (TSC). Depending on the safety and tolerability results, the DMC could propose that the study is stopped. The decision to stop the study will be taken by the TSC.

For ICH guidelines regarding termination of the study see paragraphs
4.12 (investigator)
5.21 (sponsor)
8.4 (documents)

If a trial is terminated, the following should happen:
Patient in treatment phase - terminate treatment »»»	Inform patient
Recruitment is terminated »»»	Coordinating Center will contact all sites by telephone, email or fax in order to terminate all patient recruitment as quickly as possible
Remaining drugs logged »»»	Drug accountability form
Remaining and unused drugs destroyed »»»	Drug destruction / accountability form
Drug accountability form returned to Coordinating Centre »»»	Drug accountability form, signed by the PI, must be completed for every treatment pack at site.
Completed case report forms sent to the Coordinating Centre »»»	All outstanding data must be collected as soon as possible.
Ethics Committee informed of end of trial »»»	Each PI is to inform his/her local ethics committee that the trial has been terminated.
National regulatory authorities informed of end of trial »»»	Each National Coordinator (or the Coordinating Centre) is to inform the regulatory authority in the country that the trial has been terminated.
All trial data archived in the trial study file »»»	All original dataforms and patient consent forms to be archived and kept for five years after the end of the trial.
All trial related documents and correspondence archived in the study file »»»	All documents listed in the trial study file index to be archived and kept for five years after the end of the trial.

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