Jordy van Sambeeck

Chapter 11 172 Data management and medical research ethics Data management The data obtained during this PhD-project are stored in digital files on the local servers of Radboudumc and Canisius Wilhelmina Hospital (CWZ). Published data generated or analyzed in this thesis are part of published articles and its additional files are available from the associated corresponding authors on request. In order to protect the privacy of patients, data are anonymized and personal data were removed from the files. To ensure interpretability of the data, all filenames, primary and secondary data and scripts used to provide the final results are documented along with the data. Using the patient data in future research is only possible when performed for health care improvement analyses. The datasets analyzed during these studies are available from the corresponding author on reasonable request. Declaration of Helsinki This thesis is based on the results of data analysis of patient files, which were conducted in accordance with the principles of the Declaration of Helsinki. The studies in this thesis have been conducted in order to analyze and improve provided clinical care. The studies described in Chapter 2 and 3 are retrospective studies performed in Canisius Wilhelmina Hospital (CWZ). For these studies there was a protocol approved by the Local Ethical Committee of CWZ. The studies described in chapter 4 was a retrospective patient file study performed in Radboud University Medical Center. Data for study in chapter 5 were retrospectively collected in Radboudumc, Institutional Review Board approval was obtained for this study. The study in chapter 6 was a prospective case series for which ethical approval was obtained, all patients gave informed consent. For the study in chapter 8 patients who participated in previous retrospective studies in Radboudumc and CWZ were contacted. The Institutional Review Board of Radboudumc deemed that the Medical Research Involging Human Subject Act (WMO) did not apply.