Reference:ICH ICH E8 Guideline R1 (2021) 3.3.5: Difference between revisions
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| | | [[Glossary:TAG-00076-Fea-ung|Feasibility]], [[Glossary:TAG-00055-Stu-ngs|Study design]], [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00144-Qua-gew|Quality assurance]] | ||
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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 1 — Unit 1.2.7 |
| Scope | HM |
| Document part | 3.3.5 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Feasibility, Study design, Protocol, Quality assurance |
| Comment | Critical-to-quality factors in clinical trial operations |
Content
3.3.5 Critical to Quality Factors in Operational Practice The foundation of a successful study is a protocol that is both scientifically sound and operationally feasible. A feasibility assessment involves consideration of study design and implementation elements that could impact the successful completion of clinical development from an operational perspective. [...]
