Reference:ICH ICH E8 Guideline R1 (2021) 3.3.5: Difference between revisions
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! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
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| HM | | HM | ||
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! | ! Document part | ||
| 3.3.5 | | 3.3.5 | ||
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! | ! Language | ||
| EN | | EN | ||
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! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
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! | ! Contributors | ||
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! | ! Tags (EN) | ||
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| Critical-to-quality factors in clinical trial operations | | Critical-to-quality factors in clinical trial operations | ||
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== | == Content == | ||
3.3.5 Critical to Quality Factors in Operational Practice | 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. | 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. | ||
[...] | [...] | ||
Revision as of 14:27, 29 June 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 | |
|---|---|
| Scope | HM |
| Document part | 3.3.5 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| 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. [...]
