Thesis

150 Chapter 6 Research data management The studies in this thesis were part of an external PhD studentship of the mental healthcare institution GGNet Amarum and the Radboud University. Research Data Management was conducted according to the data management policy of the Radboud University (http://www.ru.nl/rdm/) and the Behavioural Science Institute (BSI) and in accordance with the General Data Protection Regulation (GDPR: https://www.ru.nl/ privacy/english/protection-personal-data/general-data-protection-regulation-gdpr/). Research Data Management was conducted according to the FAIR principles (Findable, Accessible, Interoperable, Reusable). This thesis is based on the results of human studies, which were conducted in accordance with the principles of the Declaration of Helsinki. The study in Chapter 2 was approved by the ethical review board of GGNet. All participants started treatment between September 2003 and April 2011 and provided written informed consent. The design of the study in Chapter 3 was approved on October 10th 2011 by the medical ethics committee of the medical center of the Radboud University in Nijmegen, the Netherlands (CMO Radboud UMC: 2013/226). Prior to participation, all participants provided written informed consent after a clear explanation of the study procedures. The trial was retrospectively registered on 2013 August 28 in the Dutch Trial Register: NL3982 (NTR4154), currently accessible as https://onderzoekmetmensen.nl/nl/trial/25741. All study participants in Chapter 4 provided written informed consent, allowing us to use their routinely gathered data anonymously for scientific purposes. In Chapter 5, we used a pooled dataset of Chapters 3 and 4. The privacy of participants has been warranted using individual subject codes. A pseudonymization key linked this code with the personal data. This pseudonymization key was/is stored on a network drive that was/is only accessible to the principal investigators. The pseudonymization key was/is stored separately from the research data. The key file for Chapter 2 was destroyed after data processing was completed. The key file for Chapters 3, 4 and 5 is still stored on a secure network drive as longer term follow-up data are not yet processed. These data can only be accessed by the researchers at GGNet Amarum. The key file will be destroyed after data processing is completed. The raw data (paper and pen) are securely stored in the archive of GGNet Amarum. These data are only accessible to members at GGNet Amarum who are involved in the project. To enhance open science and transparent research practices, the publication packages associated with the publications in the Chapters 3, 4 and 5 of this dissertation are available for registered users in the Radboud Data Repository (https://data.ru.nl).

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