Govert Veldhuijzen

200 Data stewardship statement I. DATA STEWARDSHIP STATEMENT Research data management must abide to the highest standards of safety, to avoid data leaks. This safeguards scientific integrity, supports reuse of data and allows safekeeping of valuable datasets. All research data that is presented in this thesis has been obtained at the department of Gastroenterology and Hepatology, North West Hospital group Alkmaar, the Netherlands, the department of Gastroenterology and Hepatology, Radboudumc academic hospital, Nijmegen, the Netherlands, the department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, Den Bosch, the Netherlands and the department of Gastroenterology and Hepatology, Bernhoven Hospital, Uden, the Netherlands. In chapter 3, the data on educated patients is presented on endoscopy unit level based on the dashboard from Medify (software developer). For chapter 6, input in the cost model included interviews in the Reinier de Graaff hospital in Delft, the Netherlands and the Medisch Spectrum Twente in Enschede, the Netherlands. This data is archived according to Findable, Accessible, Interoperable and Reusable (FAIR) principles. 1 Primary data were mostly captured via online questionnaire websites SurveyMonkey and ZohoSurvey, accessible by password by members of the research group. This was subsequently exported into secondary data sets in Microsoft Excel or IBM SPSS Statistics. After finalization of each trial, the data was safely migrated to a local server in the department of Gastroenterology and Hepatology in the Radboudumc hospital. This server is support by the ICT department of the Radboudumc, with daily backups. The studies in this thesis including humans were all performed according to the principles of the declaration of Helsinki and Dutch ‘good clinical practice’ guidelines. 2 The author of this thesis was trained in April 2013 in ‘good clinical practice’ before patients were included in the first trial described in chapter 2. All studies had approval of the Medical Ethical Committee Boards in Alkmaar and Arnhem-Nijmegen. All study protocols were reviewed by these boards and found to be not subsidiary to the Dutch legislation regarding patient based research (Wet Mensgebonden Onderzoek – WMO). All patients provided written informed consent via the online patient questionnaires for the trials in chapter 2., 5., 6., 7. and 8. This novel method was designed with the additional approval by the Medical Ethical Committee Boards Arnhem-Nijmegen. All study protocols involving patients were registered at the clinical trial registries of Clinical Trials (clinicaltrials.gov) and the Dutch Trial register ( ntr.nl) . All data generated is included in the published articles and additional files are available upon request from the corresponding author.