Reference:ICH ICH E8 Guideline R1 (2021) 3.3.5: Difference between revisions
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| | |has_document=Document:ICH ICH E8 Guideline R1 (2021) | ||
| | |module=1 | ||
| | |unit=1.2.7 | ||
| | |scope=HM | ||
| | |doc_part=3.3.5 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00076-Fea-ung ++ TAG-00055-Stu-ngs ++ TAG-00033-Pro-oto ++ TAG-00144-Qua-gew | |||
|tags_display=[[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]] | |||
|comment=Critical-to-quality factors in clinical trial operations | |||
|content=3.3.5 Critical to Quality Factors in Operational Practice | |||
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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. | ||
[...] | [...] | ||
}} | |||
Latest revision as of 13:49, 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. [...]
