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White Paper: SCTO statisticians in Independent Data Monitoring Committees of academic studies

Authors: Michael Coslovsky, PhD; Andreas Limacher, PhD; Dik Heg, PhD; review by the members of the Statistics and Methodology Platform of the SCTO

January 2024 Guidelines doi: http://www.doi.org/10.54920/SCTO.2024.01

Abstract

The objective in this statement is to describe the role of a statistician from a Swiss Clinical Trial Organisation (SCTO) associated body when taking on the role of independent statistician in an Independent Data Monitoring Committee (IDMC) for a study conducted with the participation of a SCTO network partner. The Statistics and Methodology Platform proposes a framework for efficient collaboration between SCTO network partners to the assignment of statisticians to this role.

Imprint

Recommended form of citation

Statistics and Methodology Platform of the Swiss Clinical Trial Organisation (SCTO) (2024). White Paper: SCTO statisticians in Independent Data Monitoring Committees of academic studies. Edited by the SCTO. doi: 10.54920/SCTO.2024.01

Copyright

This publication is licensed under CC BY-NC 4.0. The content of this publication may be shared and adapted as long as you follow the terms of the license. To view a copy of the license, visit http://creativecommons.org/licenses/by-nc/4.0/. Please attribute this resource to “Swiss Clinical Trial Organisation (Regulatory Affairs Platform)” and link to the following website: www.sctoplatforms.ch

Contact

To give feedback on this publication or obtain further information, you can contact platforms@scto.ch