ICH guideline
ICH E9: Statistical Principles for Clinical Trials
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E9 |
|---|---|
| Title | Statistical Principles for Clinical Trials |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in February 1998. This document sets out the principles of statistical methodology applied to clinical trials for marketing applications submitted in the ICH regions. The principles outlined in this guidance are primarily relevant to clinical trials conducted in… |
| File | E9 Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- E9 Guideline Files published by ICH
- 1–9 FDA guidance documents based on this guideline
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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.