Reference:ICH ICH E9 Guideline 1998 2.3: Difference between revisions
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Revision as of 17:29, 15 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 3 — Unit 3.3.1 |
| Scope | HM |
| Document part | 2.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Blinding, Randomisation, Methodology |
| Comment | Design techniques to avoid bias: randomisation and blinding |
Content
2.3 Design Techniques to Avoid Bias The most important design techniques for avoiding bias in clinical trials are blinding and randomisation, and these should be normal features of most controlled clinical trials intended to be included in a marketing application. Most such trials follow a double-blind approach [...]
