Thesis

197 Research Data Management A Research data management This research followed the applicable laws and ethical guidelines. Research Data Management was conducted according to the FAIR principles. The paragraphs below specify in detail how this was achieved. Ethics This thesis is based on the results of human studies, which were conducted in accordance with the principles of the Declaration of Helsinki. The SCOPE study is approved by the the medical ethics Committee on Research involving Human Subjects (CCMO, ArnhemNijmegen) and is registered under number 2018-4309. Ethical approval was also obtained from local institutional review boards (CMO Radboud University Medical Centre and Karakter Child and Adolescent Psychiatry). The PRE-SCOPE studies (presented in Chapters 2 and 3) did not fall within the remit of the Medical Research Involving Human Subjects Acts (WMO), and has been approved by the ethics committee of the Radboud University Nijmegen Medical Centre on the basis of the Dutch Code of conduct for health research, the Dutch Code of conduct for responsible use, the Dutch Personal Data Protection Act and the Medical Treatment Agreement Act. Ethical approval was also obtained from the local review board of Karakter Child and Adolescent Psychiatry. Written informed consent was obtained from all participants. Funding This work was funded by the Korczak Foundation (Grant No. 2018–01) and was further funded by (1) the EU-AIMS (European Autism Interventions) and AIMS-2-TRIALS programmes which receive support from Innovative Medicines Initiative Joint Undertaking Grant No. 115300 and 777394, the resources of which are composed of financial contributions from the European Union’s FP7 and Horizon2020 Programmes, and from the European Federation of Pharmaceutical Industries and Associations (EFPIA) companies’ in-kind contributions, and AUTISM SPEAKS, Autistica and SFARI, and (2) the EU Horizon2020 programme CANDY (Grant No. 847818). Findable, Accessible Electronic data of the studies is stored at the secure directory networks Karakter servers and video data is stored at the secure Mediaserver of Karaker. Raw paper data is stored at the central archive of Karakter. Informed consent was obtained on paper following the procedures of the Ethic Committee. All research data remains available for 15 years after termination of the studies.

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