Maarten van der Doelen

Appendices

RESEARCH DATA MANAGEMENT

This thesis is basedon the results of human studies, whichwere conducted in accordance with the principles of the Declaration of Helsinki. The medical and ethical review board Committee on Research Involving Human Subjects Region Arnhem Nijmegen, Nijmegen, the Netherlands has given approval to conduct these studies. In addition, the collaborative studies (chapters 2, 6 and 7) published in this thesis were also approved by the institutional review boards and local committees on research involving human subjects at the Heidelberg University Hospital (Heidelberg, Germany), the Karolinska University Hospital (Stockholm, Sweden) and the Johns Hopkins University Hospital (Baltimore, Maryland, United States of America), respectively. Research data and patient reported data (questionnaires) were initially collected on paper case report forms or directly entered in CastorEDC, a cloud-based clinical data capture platform. All paper data were also entered into CastorEDC. Data sets from other institutions were transferred to Statistical Package for the Social Sciences (SPSS) files (IBM, Armonk, NY, USA). The data were managed and monitored within CastorEDC and the database was locked after ending of the study. An audit trail was incorporated to provide evidence of the activities that has altered the original data. The privacy of the participants in this study was warranted by use of encrypted and unique individual subject codes. This code correspondents with the code on the questionnaires and case report forms. The code was stored separately from the study data. The patient samples and data, including the written informed consents, are stored in the Medical Oncology department archive at the Radboudumc or archived on the site, depending on the site of participant inclusion. Digital data is stored on the servers of CastorEDC and on the Medical Oncology department server of the Radboudumc. The data will be saved for 15 years after termination of each study. Using these patient data in future research is only possible after a renewed permission by the patient as recorded in the informed consent. The datasets analyzed during these studies are available from the corresponding author on reasonable request. Data were converged from CastorEDC to SPSS for data analysis and manipulation. An audit trail which tracks every manipulation is included in SPSS.

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