E8(R1) (Step 4, 6 October 2021)
General Considerations for Clinical Studies
ICHICH guidelineClinical investigationDevices and medicinesHigh confidenceLast verified October 4, 2026
Sets out general principles for designing and conducting clinical studies, with attention to quality across the product lifecycle and an overview of the types of clinical studies.
Recognition by market
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|
| United States | Adopted | - | Vol 87 No. 69 p.21127-21129 | Effective April 11, 2022 |
| European Union | Adopted | - | EMA/CHMP/ICH/544570/1998 | Effective April 14, 2022 |
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Related standards: ISO 14155, E6(R3), E9(R1), NHMRC National Statement, Declaration of Helsinki. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
