Reference:ICH ICH E9 Guideline 1998 2.3.1: 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 | 2.3.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Emergency unblinding, Unblinding, Blinding, Medical care |
| Comment | Breaking the blind for individual subjects: conditions |
Content
[...] Breaking the blind (for a single subject) should be considered only when knowledge of the treatment assignment is deemed essential by the subject’s physician for the subject’s care. Any intentional or unintentional breaking of the blind should be reported and explained at the end of the trial, irrespective of the reason for its occurrence. The procedure and timing for revealing the treatment assignments should be documented. [...]
