General Considerations for Clinical Studies
The foundational ICH efficacy guideline describing the general principles for the design and conduct of clinical studies across a drug development programme. The R1 revision introduces "quality by design" and the concept of identifying factors critical to the quality of a study early, aligning E8 with the risk-proportionate philosophy later embedded in E6(R3).
Applies across the clinical development lifecycle for investigational medicinal products in ICH regions; a companion framework to E6 GCP and the E9 statistical principles.
- 01Identify factors critical to quality proactively during study design
- 02Adopt a proportionate, fit-for-purpose approach to study conduct and oversight
- 03Engage relevant stakeholders, including patients, in study design where appropriate
R1 revision adopted 6 October 2021, adding quality-by-design and critical-to-quality-factor concepts to the original E8 (1997).
ICH E8(R1): frequently asked questions
Quick answers to common questions about ICH E8(R1).
What is ICH E8(R1)?
ICH E8(R1) — General Considerations for Clinical Studies — is a guidance issued by the International Council for Harmonisation. The foundational ICH efficacy guideline describing the general principles for the design and conduct of clinical studies across a drug development programme. The R1 revision introduces "quality by design" and the concept of identifying factors critical to the quality of a study early, aligning E8 with the risk-proportionate philosophy later embedded in E6(R3).
Who does ICH E8(R1) apply to?
Applies across the clinical development lifecycle for investigational medicinal products in ICH regions; a companion framework to E6 GCP and the E9 statistical principles.
What are the key requirements of ICH E8(R1)?
ICH E8(R1) requires, among other things: Identify factors critical to quality proactively during study design; Adopt a proportionate, fit-for-purpose approach to study conduct and oversight; Engage relevant stakeholders, including patients, in study design where appropriate.
When was ICH E8(R1) last updated?
The current version of ICH E8(R1) dates from October 2021. R1 revision adopted 6 October 2021, adding quality-by-design and critical-to-quality-factor concepts to the original E8 (1997).
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Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
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