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Reference:ICH ICH E8 Guideline R1 (2021) 3.3.5: Difference between revisions

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|comment=Critical-to-quality factors in clinical trial operations
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|content=3.3.5 Critical to Quality Factors in Operational Practice
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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Module
| Module 1 — Unit 1.2.7
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! Scope
| HM
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! Document part
| 3.3.5
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! Language
| EN
|-
! Original entry by
| Florian Adragna
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! Contributors
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! Tags
| [[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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| Critical-to-quality factors in clinical trial operations
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== 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.
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 12:55, 16 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

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. [...]

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