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Health Canada Adopts ICH’s Genomic Sampling and Data Management Guidance

May 2, 2018

Health Canada announced its implementation of the ICH E18 guideline, which provides guidance on genomic sampling and managing genomic data from interventional and non-interventional clinical studies.

The guideline, which applies to any genomic research that uses human-derived materials, highlights critical parameters for objectively collecting, storing and using genomic samples and data. It also stresses the importance of subject privacy, data protection and obtaining informed consent.

The agency noted that Health Canada-implemented ICH guidances take precedence over its existing guidances and said it is working to remove any inconsistencies.

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