189 RESEARCH DATA MANAGEMENT A Research Data Management General information about data collection All research projects that are part of this thesis involve human subject data and were 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). The principles of Good Clinical Practice were followed throughout. Oral and written informed consent for collecting, storing and analyzing these data was obtained from all participants prior to data collection. Data were collected and stored at the Radboudumc, department of Rehabilitation, and the Donders Centre for Cognitive Neuroimaging. A data management plan and a monitor plan were composed and approved by the Board of Directors of the Radboudumc prior to data collection. Ethics The work described in chapter 3 was approved by the local medical ethical committee (Medical Ethical Committee region Arnhem-Nijmegen, CMO2014-1435). The work in chapters 4-6, part of the NA-CONTROL study, was also approved by the local medical ethical committee (Medical Ethical Committee region Arnhem-Nijmegen, CMO 2017-3740) and was registered at ClinicalTrials.gov (NCT03441347). For all the work described in this thesis, funding was provided by the Prinses Beatrix Spierfonds [W.OR16-05]. The funder has had no role in development, execution of, or reporting on all the studies and their outcomes. FAIR principles Findable, Accessible » For chapter 3, de-identified data, task materials, analyses scripts, and questionnaires are available in a data sharing collection in the Donders Repository: http://hdl.handle.net/11633/aacwcmem » For the NA-CONTROL study (chapters 4, 5 and 6) clinical data (questionnaires (*.csv) reachable workspace files (*.mat), and 3D-photography (*.obj, *.tka)) are stored in a Castor EDC database and on the Radboudumc’ department of Rehabilitation’s research servers (Q:\Research\066 NA Project\Data). Paper files (Informed consent, written questionnaires, patients’ treatment diaries) are stored in the department’s archive. The task materials, data and processing files for the MRI data, EMG and behavioral task data (hand laterality judgement task and NENS task) are archived in a Research Documentation Collection in the Donders repository https://data.donders.ru.nl/collections/di/dccn/RDC_3011151.02_799, https://doi.org/10.34973/rgem-vk59 » All data will be stored for 15 years after the completion of the NA-CONTROL study. Data are accessible upon reasonable request. Interoperable, Reusable While obtaining informed consent, individual participants had to indicate whether they
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