Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.2
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 6 â Unit 6.2.0 |
| Scope | G |
| Document part | III. Annex 1
3.11.4.5.2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Close-out visit, Essential documents, Drug accountability, Trial site |
| Comment | Site close-out activities: final confirmation steps |
Content
3.11.4.5.2 Investigator Site Selection, Initiation, Management and Close-out [...] (j) Confirming the arrangement for the retention of the essential records and the final accountability of the investigational product (e.g., return and destruction or alternative disposition, if appropriate) during site close-out activity.
