ICH E18 Guideline on genomic sampling and management of genomic data - Scientific guideline

This document provides guidance on genomic sampling and management of genomic data from interventional and non-interventional clinical studies.

Keywords: Genomic sampling, genomic data, clinical studies

Current effective version

ICH guideline E18 on genomic sampling and management of genomic data - Step 5

Adopted Reference Number: EMA/CHMP/ICH/11623/2016 Legal effective date: 28/02/2018 Summary:

The scope of this guideline pertains to genomic sampling and management of genomic data obtained from interventional and non-interventional clinical studies. Genomic research can be conducted during or after a clinical study.

Document history - First version (current)

ICH guideline E18 on genomic sampling and management of genomic data - Step 5

Adopted Reference Number: EMA/CHMP/ICH/11623/2016 Legal effective date: 28/02/2018 Summary:

The scope of this guideline pertains to genomic sampling and management of genomic data obtained from interventional and non-interventional clinical studies. Genomic research can be conducted during or after a clinical study.

ICH guideline E18 on genomic sampling and management of genomic data - Step 3

Draft: consultation closed Consultation dates: 01/02/2016 to 31/05/2016 Reference Number: EMA/CHMP/ICH/11623/2016 Summary:

The main objective of this guideline is to provide harmonised principles of genomic sampling and management of genomic data in clinical studies. This guideline 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. Further objectives of this guideline are to increase awareness and provide considerations regarding subject privacy, data protection, informed consent and transparency of findings. This guideline is intended to foster interactions amongst stakeholders, including drug developers, investigators and regulators, and to encourage genomic research within clinical studies.