209 Withdrawal of individual subjects Subjects can leave the study at any time for any reason if they wish to do so without any consequences. The investigator can decide to withdraw a subject from the study for (urgent) medical reasons. Safety reporting Temporary halt for reasons of subject safety In accordance with section 10, subsection 4, of the WMO, the investigator will suspend the study if there is sufficient ground that continuation of the study will jeopardise subject health or safety. The investigator will notify the accredited METC without undue delay of a temporary halt including the reason for such an action. The study will be suspended pending a further positive decision by the accredited METC. The investigator will take care that all subjects are kept informed. Adverse events Adverse events (AEs). AEs classified as related or unrelated to the surgical procedure where pain, dysphagia and xerostomia for less than seven days were considered a normal post-operative course.68, 91 Submandibular swelling for less than four weeks without other sequelae was considered a normal post-operative course. All adverse events, possibly related to the procedure or the study reported spontaneously by the subject or observed by the investigator or his staff, will be recorded. Serious adverse events In case of an SAE or Suspected Unexpected Serious Adverse Reaction (SUSAR), we will internally discuss whether the SAE is related to the procedure. When the SAE seems related to the procedure, we will discontinue the study for consultation with the IRB. SAEs are expected especially during the first weeks, so we will keep at least two weeks between each procedure. The investigator will report the SAEs through the web portal ToetsingOnline to the accredited IRB that approved the protocol within seven days of first knowledge for SAEs that result in death or are life-threatening, followed by a period of a maximum
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