Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator’s Brochure (IB)
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 2 — Unit 2.1.4 |
| Scope | G |
| Document part | GLOSSARY - Investigator’s Brochure (IB) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator's brochure, Definition, Clinical data |
Content
Investigator’s Brochure (IB) A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human participants (see Appendix A).
