Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 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 2 â Unit 2.3.1 |
| Scope | G |
| Document part | III. Annex 1
2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator, Investigator qualification, Training, Requirements |
| Comment | Investigator qualifications and training requirements |
Content
2. INVESTIGATOR 2.1 Qualifications and Training 2.1.1 The investigator(s) should be qualified by education, training and experience to assume responsibility for the proper conduct of the trial and should provide evidence of such qualifications.
2.1.2 The investigator should be familiar with the appropriate use of the investigational product(s) as described in the protocol, in the current Investigatorâs Brochure, in the product information and/or in other information sources provided by the sponsor. [...]
