41 NA-CONTROL STUDY PROTOCOL 2 Missing data Throughout data collection, measures will be taken, where possible, to minimise the occurrence of missing data. These measures include those mentioned under 3.6, Patient retention, as well as clear communication with individuals involved in data collection. Once data collection is complete, the extent to which data is missing will be evaluated. Any patterns in missing data, especially in relation to the intervention groups, will be explored. If necessary and possible, missing data will be imputed. Monitoring Data monitoring As this study has a negligible risk classification it does not require a data monitoring committee. The study will be monitored by an independent, certified monitor according to the Netherlands Federation of University Medical Centres’ guidelines for monitoring of clinical studies. The frequency and extent to which the study is monitored is defined in a monitor plan that has been submitted to and approved by the Board of Directors of the Radboudumc. (Serious) Adverse events All adverse events (AEs) reported spontaneously by the subject or observed by the investigator or the treatment team will be recorded. All AEs will be 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 physician or a medical specialist. All serious adverse events (SAEs) will be reported to the accredited medical ethical committee following national regulations. Good Clinical Practice Ethical conduct of the study The study will be conducted according to the principles of the Declaration of Helsinki (version 64th WMA General Assembly, Fortaleza, Brazil, October 2013) and in accordance with the Dutch Medical Research Involving Human Subjects Act (WMO). All personnel involved in the conduction of this study has received training on GCP. The principles of GCP will be followed throughout the conduction of this study. Protocol amendments All amendments will be notified to the accredited medical ethical committee. Nonsubstantial amendments will not be notified but will be recorded and filed by the investigator. Substantial amendments will not be implemented until approval of the accredited medical ethical committee has been obtained. In case changes or additions to the protocol might influence participants’ decision to participate in the study, active participants will be informed and a new informed consent procedure will be started.
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