ICH E18 Genomic Sampling Guidelines


E18 Genomic Sampling

E18 Genomic Sampling and Management of Genomic Data

The ICH Harmonised Guideline was finalized under Step 4 in August 2017.

This document provides 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.

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

Date of Step 4: 6 September 2017

Status: Step 5

Guidelines (Click the links below for complete guidelines)

Endorsed Documents (Click the links below for complete guidelines)

WG Presentations / Trainings (Click the links below for complete guidelines)

*These Guidelines Belongs to ICH website.

ICH E18 Genomic Sampling Guidelines:

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