October 23, 2017What's New
CBI's Risk-Based Trial Management and Monitoring Conference is just TWO weeks away! Join your peers, thought-leaders and trial counterparts to collaborate on the growing challenges and solutions for ensuring RBM data quality. Learn how to reduce the complexity of implementing an efficient RBM methodology, system adoption, process integration and much more! Visit www.cbinet.com/RBM to view the full conference agenda.
RBM Risk Assessment ? What are, and how to mitigate the risks from the patient, study, site and sponsor perspectives? - Presented by Dr. Jules T. Mitchel, President, Target Health Inc.
Assessing risk is an ongoing process for any industry, and clearly the impact of all risks are not equal. In the clinical research environment, the primary concern is the safety risk to the patient when taking an experimental medicinal product or using an unapproved medical device. Other risks include the impact of not following the protocol and not being complaint with rules and regulations. This session presents a model for risk assessment and provides concrete examples. Risk mitigation:
1. Identify risk factors
a) the severity of the event, should it happen
b) the likelihood that the event would happen
c) the likelihood of detecting the event
2. Risk mitigation strategies for each risk
3. Assessment of unique risks associated with specific studies
4. A model is presented with examples
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors.
Joyce Hays, Founder and Editor in Chief of On Target
Jules Mitchel, Editor