148 Appendices 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 The chapters within this thesis are based on the results of human studies that were conducted in accordance with the principles of the declaration of Helsinki. All studies met the requirements of the medical ethical committee review – Regio OostNederland, Nijmegen, The Netherlands and were approved by the Board of Directors of the Radboud University Medical Centre. The principles of Good Clinical Practice were followed. All participants provided written informed consent prior to any study procedure. The protocol of the studies described in chapters 3 and 4 was registered at ClinicalTrials.gov [NTC04180098]. The privacy of the participants was warranted through the use of encrypted individual participant codes. The encrypted codes were stored separately from the research data and only accessible to members of the project based on their role. The chapters 2,3,4 and 5 were funded by the Jacques and Gloria Gossweiler Foundation, and chapters 3 and 4 were additionally funded by a grant from Ipsen Pharmaceuticals. The funders had no role in the development or executing of the study protocol, nor in the interpretation or reporting of study outcomes. FAIR-principles Findable: Data were stored on the server of the Rehabilitation department at the Radboud University Medical Centre (Q:\Research\102 MOVE-HSP). The paper versions of the case report forms were stored at the Rehabilitation Department (Room M352.04.141) and transferred to the Rehabilitation department archive after publication of the study (Room M653.-1.337). Accessible: All data is available upon reasonable request by contacting the staff secretary of the Rehabilitation department of rehabilitation at the Radboud University Medical Centre, Nijmegen (NL): (secretariaatstaf.reval@radboudumc.nl). Interoperable: Documentation with reference to locations and descriptions was added to the data sets to make the data interpretable. Data were stored using the following formats: XLSX (Microsoft Office Excel), .SAV and .SPS (SPSS) and .MAT (Matlab Mathworks, USA). No existing data standards were used such as vocabularies, ontologies or thesauri.
RkJQdWJsaXNoZXIy MjY0ODMw