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The Anonymization of Clinical Trial Data: Methodology Course
October 25, 2016 - October 26, 2016
This two-day comprehensive course, led by Dr Khaled El Emam, will provide attendees with the skills needed to manage the risk of re-identification when clinical trial data is shared for secondary purposes. Multiple techniques and controls are covered to ensure that the risk is very small and defensible in the eyes of regulators. Contemporary standards for anonymizing clinical trial data will be covered, such as IOM and PhUSE. We will go through a series of case studies on anonymizing datasets and discuss specific concerns and issues with small datasets and rare diseases. This course will also have a particular focus on anonymization for EMA Policy 0070.
Our peer-reviewed, standards-based and scalable risk-based anonymization methodology has been used across North America and the European Union for anonymizing health data for over seven years. This methodology provides quantitative methods to objectively measure risk, and a well-defined and auditable approach for managing those risks. Its application to clinical trials is supported by case studies and discussions of specific data release mechanisms, such as portals.