View {title}

Central Data Monitoring in Clinical Trials

Abstract

The complexity of clinical trials has increased significantly during the last two decades. This led to major challenges for quality assurance and control, in particular for multicentre trials. It became apparent that there is a need to complement conventional monitoring at the study sites (on-site monitoring) by new monitoring approaches. Even though central data monitoring (CDM) has become well established in clinical research, the scope and extent of it is not clear among researchers, particularly in the academic setting. This fact sheet examines CDM in detail, describing its contribution to data quality and study oversight as well as its implementation. In addition, it addresses inconsistent terminology and the application of CDM in guidance documents.

Imprint

Recommended form of citation

Monitoring Platform of the Swiss Clinical Trial Organisation (SCTO) (2020): Central Data Monitoring in Clinical Trials. Edited by the SCTO. doi: 10.54920/SCTO.2020.01

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 (Monitoring Platform)” and link to the following website: www.sctoplatforms.ch.

Contact

To give feedback on this publication or obtain further information, you can contact or use the contact form below.

Help us to improve our resources