Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.13
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 | |
|---|---|
| Scope | G |
| Document part | III. Annex 1
2.13 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Investigator reporting obligations at trial completion |
Content
2. INVESTIGATOR [...] 2.13 Reports Upon completion of the trial, the investigator, where applicable, should inform the institution. The investigator/institution should provide the IRB/IEC with a summary of the trialâs outcome and, if applicable, the regulatory authority(ies) with any required reports.
