You should notify the REC which gave a favourable
opinion of the research (the ‘main REC’) in writing of the conclusion or
early termination of a study using the appropriate form.
Declaring the end of the study
separate forms for use in clinical trials of investigational medicinal
products (CTIMPs) and all other research.
You should send the appropriate form within 90 days of
the end of the study, or within 15 days if the study is terminated
early. If the study has been terminated early you should provide
Temporary halt of a study
Where the sponsor halts a study temporarily for safety
reasons, this should be notified to the main REC by submitting a notice
of substantial amendment. The form should clearly explain the reasons
for the halt and the scope, e.g. stopping recruitment and/or
interrupting the treatment of participants already included.
To restart the study, the sponsor should submit a
further notice of substantial amendment for ethical review. Evidence
should be provided that it is safe to restart the trial. If the sponsor
decides not to recommence the trial after a temporary halt, the end of
the study should be declared.