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The Anonymization Methodology for Clinical Trials Data
January 21, 2016 - January 22, 2016
In this two-day comprehensive course, The Anonymization Methodology for Clinical Trials Data, 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.
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.
Dr. Khaled El Emam is the founder and CEO of Privacy Analytics. He is also a senior investigator at the Children’s Hospital of Eastern Ontario Research Institute, a professor at the University of Ottawa and held the Canada Research Chair in Electronic Health Information from 2005 to 2015. He is a renowned expert in statistical de-identification and re-identification risk measurement. He is one of only a handful of individual experts in North America qualified to anonymize Protected Health Information under the HIPAA Privacy Rule.