Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.10.1.6
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 6 â Unit 6.4.2 |
| Scope | G |
| Document part | III. Annex 1
3.10.1.6 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Clinical study report, Risk-based quality management, Sponsor, Risk |
| Comment | Risk reporting: sponsor summary of quality issues |
Content
3.10.1.6 Risk Reporting The sponsor should summarise and report important quality issues (including instances in which acceptable ranges are exceeded, as detailed in section 3.10.1.3) and the remedial actions taken and document them in the clinical trial report (see ICH E3).
