Bio-IT World Podcast: Evaluating a Risk-based Approach to Good Clinical Practice
The verification of source documents by study monitors at investigational sites is considered a good clinical practice by regulatory authorities overseeing clinical research, and is extremely important to ensuring data quality in clinical trials. Today’s challenging environment is prompting study teams to explore the use of risk-based approaches to monitoring that do not compromise data quality, but allow limited resources to be directed more effectively to where they’re most needed and to the most critical review activities.
In this podcast, industry experts and executives from Medidata will address questions such as:
- Why are regulatory agencies and industry open to evaluating the new approaches in site monitoring and source document verification (SDV), and what attitudes and reactions towards less than 100% SDV?
- What factors do research sponsors need to consider in adopting risk-based site monitoring?
Patricia Beers Block
Vice President, Strategic Regulatory Initiatives
Medidata Solutions Worldwide
pbeersblock@mdsol.com
Steve Young
Senior Product Director
Medidata Solutions Worldwide
syoung@mdsol.com
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