Reference:ICH ICH E8 Guideline R1 (2021) 6.2.2: Difference between revisions
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| | | [[Glossary:TAG-00025-Sub-mer|Trial participant]], [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00287-Sto-pre|Stopping rules]], [[Glossary:TAG-00329-Saf-lne|Safety]] | ||
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | ICH ICH E8 Guideline R1 (2021) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E8 Guideline |
| Version / Revision | R1 (2021) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | ICH guideline E8 (R1) on general considerations for clinical studies |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 5 — Unit 5.4.1 |
| Scope | HM |
| Document part | 6.2.2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Trial participant, Protocol, Stopping rules, Safety |
| Comment | Withdrawal criteria for individual subjects |
Content
6.2.2 Withdrawal Criteria Clear criteria for stopping treatment or study procedures for a study participant while remaining in the study are necessary to ensure the protection of the participants but should also minimise loss of critical data.
