Stephanie Vrede

213 A RESEARCH DATA MANAGMENT RESEARCH DATA MANAGMENT Ethics and privacy This thesis is based on the results of human studies (or existing data from published papers), which were conducted in accordance with the principles of the Declaration of Helsinki. All collected patient material is coded and pseudonymized with an individual study number, according to the protocol ‘Code for proper use of human tissue’. The medical ethical committee Radboudumc CMO, Nijmegen, the Netherlands has given approval to conduct the studies in chapter 2 through 7 and concluded that these studies fall not under the Medical Research Involving Human Subjects Act (WMO). Chapter 2 through 7 were also approved by the Institutional Review Board of all participating centers. Data collection and storage Some of the data for chapter 7 was collected through electronic Case Report Forms (eCRF) using CASTOR EDC. From Castor EDC data were exported to SPSS version 25.0 (IBM, New York, NY, USA). Data for the other chapters was added to existing datasets in SPSS 25.0 (IBM, New York, NY, USA) of previously published studies. The data of the PhD project is stored according the FAIR principles on the Radboudumc department server: H:\Onderzoek\ONCO-Endorisk\Stephanie and under H:\Onderzoek\ ONCO-Endorisk\Biomarkers endometrial cancer. There will be no patient information on my private computer. Study material (sections, blocks and DNA) of patients are anonymized stored at the pathology department. Availability of data The studies of chapter 2 through 5 and 7 are published open access, chapter 6 is submitted. The data will be archived for 15 years after termination of the study. Reusing the data for future research is only possible after a renewed permission of the medical ethical review board and participants. The anonymous datasets that were used for analysis are available from the corresponding author upon reasonable request.

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