Reference:ICH ICH E8 Guideline R1 (2021) 7
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| 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. […]
