Working Paper Concept Paper Version 1 This version is not peer-reviewed

Sharing of Data from Clinical Research Projects – Guidance from the Swiss CTU Network

Version 1 : Received: 27 June 2020 / Approved: 28 June 2020 / Online: 28 June 2020 (19:46:40 CEST)

How to cite: Gahl, B.; Haynes, A.; Sluka, C.; Dupuis-Lozeron, E.; Jörger, F.; Schur, R.; Christen, A.; Trelle, S. Sharing of Data from Clinical Research Projects – Guidance from the Swiss CTU Network. Preprints 2020, 2020060344 Gahl, B.; Haynes, A.; Sluka, C.; Dupuis-Lozeron, E.; Jörger, F.; Schur, R.; Christen, A.; Trelle, S. Sharing of Data from Clinical Research Projects – Guidance from the Swiss CTU Network. Preprints 2020, 2020060344

Abstract

Objectives: Data sharing has become a requirement of many funding bodies and is becoming a scientific standard in many disciplines. In medical research, however, data sharing can conflict with clinicians’ obligation to protect patients’ privacy. General recommendations on data sharing exist also for clinical research, but so far lack practical and Swiss-specific aspects. The objective of this document is to provide practical recommendations for all relevant aspects of data sharing in agreement with legislation in Switzerland. Methods: This document was written by members of the Swiss CTU Network, a network of academic clinical trial units. The process did not follow a formalized Delphi process. After an internal consensus round, this report is now published as pre-print for external review. A second version will incorporate external comments. We plan to publish this document as a text in progress, as we expect relevant changes in related fields such as the development of further dedicated medical repositories or methodological advances in anonymization techniques. Results: We developed principles and practical recommendations with respect to informed consent, data management plan, anonymization, data structure and format, coding of variables, metadata and documentation, version control, selection of repository, requesting and use of data. We also provide a summary of legal aspects relevant for the Swiss context. Conclusions: The intension to share data has an impact not only after a clinical trial or an observational study is completed, but also during the planning period, the conduct and the analysis phase. Clinical researchers need to be aware at the beginning of a study on how to inform patients and at least the amount of work related to preparing data for sharing, metadata, and any further documentation. This report provides details of aspects to be considered, suggests decision criteria, and provides examples and checklists, in order to support data sharing in practice.

Subject Areas

clinical research; data sharing

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