RESEARCH DATA MANAGEMENT 281 Research data management General information about the data collection 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 and privacy This thesis consists of chart review (chapter 2), a qualitative interview study and a secondary analysis (chapter 3 and 5), three studies that combine video observations with (focus group and individual) interviews (chapter 4, 6 and 8) and a quantitative studies that used video observations (chapter 7). All studies that included humans (children, professionals, and informal caregivers) were conducted in accordance with the principles of the 1964 Declaration of Helsinki and its later amendments. All study protocols were approved by the Medical and Ethical Review board Committee of the region Arnhem Nijmegen, Nijmegen, The Netherlands. Written informed consent was obtained from all study participants (aged 12 years and older and able to sign) and their parents, prior to any study procedure. If possible, younger children also signed the informed consent to recognize their volition/agency. The privacy of the participants in all studies of this thesis was warranted using encrypted and unique individual subject codes. The encrypted keys were stored separately from the research data and were only accessible to members of the project who needed access based on their role within the project. The video material was stored with the encrypted keys as this data was not anonymous. FAIR principles Findable: Data were stored on a shielded part of the server of the research department at the Radboud university medical center (Q\reval_onderzoek\Research\074 Mito Disease in Children). Data containing participants’ personal information and identifiers are kept in a separate folder (H\revaldata$\Onderzoek\Mito Disease in Children 074) and are only accessible for the first promotor and project leader. The paper CRF files were stored at the department of Rehabilitation (roomM352.04.135) and were/are transferred to the department archive after study publication. Accessible: Only researchers assigned by the project leader have access to the databases with the research data. It is not possible to make the data available in a public repository because participants only gave informed consent to use their data for the purposes described on the signed informed consent form. All data are available on reasonable request by contacting the corresponding author (marieke. lindenschot@han.nl).
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