Reference:ICH ICH E8 Guideline R1 (2021) 5.: Difference between revisions
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| | | [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00302-Ada-die|Adaptive design]], [[Glossary:TAG-00055-Stu-ngs|Study design]], [[Glossary:TAG-00011-Inv-tud|Investigational drug (IMP)]] | ||
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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 2 — Unit 2.1.3 |
| Scope | HM |
| Document part | 5. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Protocol, Adaptive design, Study design, Investigational drug (IMP) |
| Comment | Design elements for master protocol and platform trial studies |
Content
5. DESIGN ELEMENTS AND DATA SOURCES FOR CLINICAL STUDIES […] Master protocol studies allow for the investigation of multiple drugs or multiple conditions under a shared framework. Platform studies allow for multiple drugs to be investigated in a continuous manner, with different drugs entering the study at different times and leaving the study based on pre-specified decision rules.
