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Implementing Risk-Based Monitoring
Session Chair(s)
Willie Muehlhausen, DVM
Co-Founder
SAFIRA Clinical Research, Ireland
Risk-based monitoring (RBM) promises to improve quality in clinical research, and may help limit the growing cost of clinical trials. Recommendations have been outlined by regulatory bodies including FDA’s Guidance on RBM, and EMA’s reflection paper. Transcelerate BioPharma has also published a position paper on implementation. This symposium will look at several aspects of RBM implementation, using a number of case examples to explore and contrast the data analytics approach using central statistical monitoring and the development and use of key risk indicators. Importance will be placed on how the cause of the findings can be identified and classed by seriousness – from poor protocol understanding to intent to cheat. We will also discuss the operational implications of the findings in terms of the resulting corrective actions.
Learning Objective : Identify how data analytics tools can be used to identify sites at risk and drive corrective actions; Describe an approach to identifying pertinent risk indicators for risk-based monitoring (RBM) implementation; Explain how another company has implemented RBM including the related process change required.
Speaker(s)
Sponsor Perspective on Changes Made Within the Organization to Implement Risk-Based Monitoring
Roland Rich
Novartis Pharma AG, Switzerland
Operational Expert, Quality and Compliance DevQA
Therapeutic Area Key Risk Indicators: Digestive Disease
Duncan Hall
TRI, United States
Chief Executive Officer
Ensuring Data Quality and Detecting Potential Fraud
Erik Doffagne, MS
CluePoints, Belgium
Product Manager