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.
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09:30 | |
| 09:35 | RBQM in CDM – Getting ready for targeted querying? |
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10:05 | Risk-based statistical programming QC at Danone/Nutricia by Paul Vervuren (Principal Statistical Programmer) and Gertjan van Maaren (Team Leader Statistical Programming), Danone, Utrecht |
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10:35 | 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 |
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11:00 |
Panel discussion with speakers |
Pharmaceutical Statistics and Data Management 