Reference:ICH ICH E6 Guideline R3 (2025) II 7.4: Difference between revisions
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| | | [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00076-Fea-ung|Feasibility]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00317-Obj-set|Objective]] | ||
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | ICH ICH E6 Guideline R3 (2025) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E6 Guideline |
| Version / Revision | R3 (2025) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | GUIDELINE FOR GOOD CLINICAL PRACTICE |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 2 — Unit 2.1.3 |
| Scope | G |
| Document part | II
7.4 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Protocol, Feasibility, Sponsor, Objective |
| Comment | Feasibility and proportionality in trial processes |
Content
7.4 Trial processes should be operationally feasible and avoid unnecessary complexity, procedures and data collection. Trial processes should support the key trial objectives. The sponsor should not place unnecessary burden on participants and investigators.
