Reference:ICH ICH E8 Guideline R1 (2021) 7: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:ICH ICH E8 Guideline R1 (2021) | ||
| | |module=3 | ||
| | |unit=3.2.2 | ||
| | |scope=G | ||
| | |doc_part=7 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00077-Inc-gsk ++ TAG-00033-Pro-oto ++ TAG-00317-Obj-set | |||
|tags_display=[[Glossary:TAG-00077-Inc-gsk|Inclusion criteria]], [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00317-Obj-set|Objective]] | |||
|comment=Critical-to-quality factors: eligibility criteria | |||
|content=Consideration in identifying critical to quality factors | |||
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Consideration in identifying critical to quality factors | |||
[…] | […] | ||
The eligibility criteria should be reflective of the study objectives and be well documented in the clinical study protocol. […] | The eligibility criteria should be reflective of the study objectives and be well documented in the clinical study protocol. […] | ||
}} | |||
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 3 — Unit 3.2.2 |
| Scope | G |
| Document part | 7 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Inclusion criteria, Protocol, Objective |
Content
Consideration in identifying critical to quality factors […] The eligibility criteria should be reflective of the study objectives and be well documented in the clinical study protocol. […]
