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Reference:ICH ICH E9 Guideline 1998 III: Difference between revisions

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|tags_display=[[Glossary:TAG-00055-Stu-ngs|Study design]], [[Glossary:TAG-00142-Mul-ent|Multicentre trial]], [[Glossary:TAG-00056-Bio-tik|Biostatistics]]
 
|comment=Trial design configurations: parallel, crossover, factorial
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|content=III. TRIAL DESIGN CONSIDERATIONS
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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Module
| Module 1 — Unit 1.2.7
|-
! Scope
| HM
|-
! Document part
| III
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00055-Stu-ngs|Study design]], [[Glossary:TAG-00142-Mul-ent|Multicentre trial]], [[Glossary:TAG-00056-Bio-tik|Biostatistics]]
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! Comment
| Trial design configurations: parallel, crossover, factorial
|}
 
== Content ==
III. TRIAL DESIGN CONSIDERATIONS
3.1 Design Configuration
3.1 Design Configuration
3.1.1 Parallel Group Design
3.1.1 Parallel Group Design
Line 64: Line 34:
3.6 Data Capture and Processing
3.6 Data Capture and Processing
[...]
[...]
}}

Latest revision as of 13:49, 16 July 2026



Document information
Reference ICH ICH E9 Guideline 1998
Validity area ICH
Scope(s) HM
Document name ICH E9 Guideline
Version / Revision 1998
Status Current
Document type International guideline
Language(s) EN
Description STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9
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 III
Language EN
Original entry by Florian Adragna
Contributors
Tags Study design, Multicentre trial, Biostatistics

Content

III. TRIAL DESIGN CONSIDERATIONS 3.1 Design Configuration 3.1.1 Parallel Group Design […] 3.1.2 Crossover Design […] 3.1.3 Factorial Designs […] 3.2 Multicentre Trials […] 3.3 Type of Comparison 3.3.1 Trials to Show Superiority […] 3.3.2 Trials to Show Equivalence or Non-inferiority [...] 3.3.3 Trials to Show Dose-response Relationship [...] 3.4 Group Sequential Designs [...] 3.5 Sample Size [...] 3.6 Data Capture and Processing [...]

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