Reference:ICH ICH E8 Guideline R1 (2021) 7: Difference between revisions
From GxPlex
Gxplex admin (talk | contribs) m 1 revision imported |
imported>GxPlexBot Import from GxPlex Excel |
||
| Line 4: | Line 4: | ||
|RefDocPart=7 | |RefDocPart=7 | ||
|RefLanguage=EN | |RefLanguage=EN | ||
| | |RefTags=TAG-00077-Inc-gsk ++ TAG-00033-Pro-oto ++ TAG-00317-Obj-set | ||
| | |RefModule=3 | ||
| | |RefUnit=3.2.2 | ||
}} | }} | ||
| Line 14: | Line 14: | ||
|- | |- | ||
! colspan="2" class="gplx-infobox-header" | Reference Details | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Module | |||
| Module 3 — Unit 3.2.2 | |||
|- | |- | ||
! Scope | ! Scope | ||
| Line 30: | Line 33: | ||
| | | | ||
|- | |- | ||
! Tags | ! Tags | ||
| | | [[Glossary:TAG-00077-Inc-gsk|Inclusion criteria]], [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00317-Obj-set|Objective]] | ||
|- | |||
|- | |||
| | |||
|- | |- | ||
! Comment | ! Comment | ||
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 3 — Unit 3.2.2 |
| Scope | G |
| Document part | 7 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Inclusion criteria, Protocol, Objective |
| Comment | Critical-to-quality factors: eligibility criteria |
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. […]
