The concept of risk management in the context of Clinical Research has existed for quite some years and various guidelines have been published, like the EMA ‘Reflection paper on risk-based quality management in clinical trials’ 2013. Risk-based management in clinical trials focuses on identifying the most important risks in a trial and setting them as a priority in order to prevent and avoid potential disruption.

During this event, there were 3 presentations discussing concrete examples and applications
of risk-based approaches within data management, statistical programming and
statistics in the setting of clinical research. You can now view the presentation slides below by clicking on the links.




RBQM in CDM – Getting ready for targeted querying?

by Peter Stokman (business lead RAVEN, Clinical Data Management), Bayer, Berlin


Risk-based statistical programming QC at Danone/Nutricia

by Paul Vervuren (Principal Statistical Programmer) and Gertjan van Maaren (Team Leader Statistical Programming), Danone, Utrecht


Using central monitoring to detect data fabrication in multi-center clinical trials

by Rutger van den Bor (assist. professor in Biostatistics, Julius Center) UMCU, Utrecht


Panel discussion with speakers