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# Draft Genomic Sampling Guidance Out
- URL: https://www.fdaweb.com/draft-genomic-sampling-guidance-out/
- Published: 2016-06-02T12:00:00.000Z
- Updated: 2026-09-14T21:06:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135820

FDA has issued a draft ICH harmonized guidance, *E18 Genomic Sampling and Management of Genomic Data*, that to provide harmonized principles of genomic sampling and management of genomic data in clinical studies. The [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM504556.pdf?ref=fdaweb.com) is intended to facilitate genomic studies implementation by enabling a common understanding of critical parameters for the unbiased collection, storage, and optimal use of genomic samples and data. It also is to increase awareness and provide considerations on subject privacy, data protection, informed consent, and transparency of findings.

The guideline’s scope pertains to genomic sampling and management of genomic data from interventional and non-interventional clinical studies. It addresses use of genomic samples and data irrespective of the timing of analyses and both pre-specified and non-pre-specified use. The focus is on the general principles of collection, processing, transport, storage, and disposition of genomic samples or data, within the scope of an informed consent, the document says.