Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g)
From GxPlex
| Document information | |
|---|---|
| Reference | ICH ICH E6 Guideline R3 (2025) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E6 Guideline |
| Version / Revision | R3 (2025) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | GUIDELINE FOR GOOD CLINICAL PRACTICE |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.3.1 |
| Scope | G |
| Document part | III. Annex 1
3.16.1 (g) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Unblinding, Blinding, Data integrity |
Content
3.16.1 Data Handling [...] (g) Procedures should be in place to describe unblinding; where applicable; these descriptions should include:
(i) who were unblinded, at what timepoint and for what purpose they were unblinded; (ii) who should remain blinded; (iii) the safeguards in place to preserve the blinding.
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