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# ICH Guide on Genomic Sampling and Data
- URL: https://www.fdaweb.com/ich-guide-on-genomic-sampling-and-data/
- Published: 2018-03-01T12:00:00.000Z
- Updated: 2026-09-14T23:26:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140878

FDA has posted an International Council for Harmonization [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM504556.pdf?ref=fdaweb.com) “E18 Genomic Sampling and Management of Genomic Data.” The document is intended to provide harmonized principles for genomic sampling and managing genomic data in clinical studies. It also is structured to facilitate the implementation of genomic studies by enabling a common understanding of critical parameters for the unbiased collection, storage, and optimal use of genomic samples and data. Additionally, the guidance intends to increase awareness and provide a reminder about subjects’ privacy, data protection, suitable informed consent, and the need to consider transparency of findings in line with local legislation and regulations.