Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.4.2
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 3.2.1 |
| Scope | G |
| Document part | III. Annex 1
2.4.2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Ethics committee, Protocol, Informed consent, Investigator responsibilities, Enrolment |
Content
2.4 Communication with IRB/IEC [...] 2.4.2Before initiating a trial, the investigator/institution should have a documented and dated approval/favourable opinion from the IRB/IEC for the trial protocol, informed consent materials, participant recruitment procedures (e.g., advertisements) and any other trial-related information to be provided to participants.
