Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (c)
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 5 — Unit 5.3.3 |
| Scope | G |
| Document part | III. Annex 1
3.13.2 (c) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Sponsor safety reporting, Reference safety information, Expectedness, Investigator's brochure, Expedited reporting |
Content
3.13.2 Safety Reporting [...] (c) Safety reporting to regulatory authorities should be undertaken by assessing the expectedness of the reaction in relation to the applicable product information (e.g., the reference safety information (RSI) contained within the Investigator’s Brochure or alternative documents) in accordance with applicable regulatory requirements. Refer to ICH E2F Development Safety Update Report for more information about RSI.
