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GUIDANCE DOCUMENT

E18 Genomic Sampling and Management of Genomic Data Guidance for Industry March 2018

Final

E18 Genomic Sampling and Management of Genomic Data Guidance for Industry

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

The main objective of this guidance is to provide harmonized principles of genomic sampling and
management of genomic data in clinical studies. This guidance will 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. This guidance also intends to
increase awareness and provide a reminder regarding subjects’ privacy, protection of the data
generated, the need to obtain suitable informed consent, and the need to consider transparency of
findings in line with local legislation and regulations.

This guidance is intended to foster interactions among stakeholders, including drug developers,
investigators and regulators, and to encourage genomic research within clinical studies.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.