What is the procedure?
Sometimes there are valid reasons to believe that continuation of a study would lead to unacceptable risks for the subject. In that case, the sponsor must put the study on hold until a further positive decision has been obtained.
The on hold decision must be reported immediately if it concerns the safety of the subject, and the reason must be stated. In all other cases, a notification period of a maximum of 15 days applies.
What should I submit?
Send the on hold notification, along with a cover letter and B5 form, by email in attachment(s) to email@example.com.