Page 68 - Demo

Chapter 366Follow-upAfter the final cycle and unblinding, the participant’s substitute decision maker(s) and clinician will decide on further continuation of MPH treatment before the follow-up measurement. Although a dose titration phase precedes the trial to have a fixed dosage during the N-of-1 trial, participants can switch from dosage or discontinue with MPH in consultation with the treating physician in the follow-up period.Safety evaluationSubjects can leave the study at any time for any reason. The investigator may decide to withdraw a subject from the study for urgent medical reasons. Reasons may include occurrence of treatment-related SAEs or suspected unexpected serious adverse reaction (SUSAR), deterioration of symptoms that require a treatment other than the medication of the trial, and a sudden and acute medical condition related or unrelated to SMS that may interfere with the study. Any sign that indicates resistance among children and mentally incompetent participants, which is defined and discussed with parents and caregivers in advance, will lead to discontinuation of the trial. Completed cycles before withdrawal of a participant will still be analysed. In case of drop-out, a new participant that meets the inclusion criteria will be recruited with a newly randomized sequence. The sponsor will suspend the study if there is sufficient ground that continuation of the study will jeopardise subject health or safety.Monitoring will be conducted by independent qualified monitors from the Clinical Monitoring Center (CMC). All adverse events (AEs) will be monitored and followed until they have abated, or until a stable situation has been reached. Depending on the event, follow-up may require additional tests or medical procedures as indicated, and/or referral to the general practitioner or a medical specialist.Data collection and managementAll data will be collected and handled in accordance with the EU General Data Protection Regulation, the Dutch Act on Implementation of the General Data Protection Regulation and Amsterdam UMC standard operating procedures. The Case Report Forms (CRFs) and trial specific documents Annelieke Muller sHL.indd 66 14-11-2023 09:07