ICH guideline
ICH E18: Genomic Sampling and Management of Genomic Data
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E18 |
|---|---|
| Title | Genomic Sampling and Management of Genomic Data |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised 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… |
| File | E18 Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E18 Step 4 Presentation Files published by ICH
- 1–9 FDA guidance documents based on this guideline
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.