Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.11 – 2.12.14
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 4 — Unit 4.2.1 |
| Scope | G |
| Document part | III. Annex 1
2.12.11 – 2.12.14 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Essential documents, Archiving, Investigator responsibilities, Trial site, Requirements |
Content
2.12.11 The investigator/institution should maintain the trial records as specified in Appendix C and as required by the applicable regulatory requirement(s). The investigator/institution should have control of all essential records generated by the investigator/institution before and during the conduct of the trial.
2.12.12 The investigator/institution should retain the essential records for the required retention period in accordance with applicable regulatory requirements or until the sponsor informs the investigator/institution that these records are no longer needed, whichever is the longest. The investigator/institution should take measures to ensure availability, accessibility and readability and to prevent unauthorised access and accidental or premature destruction of these records (see Appendix C).
2.12.13 The investigator/institution should keep the sponsor informed of the name of the person responsible for maintaining the essential records during the retention period;for example, when the investigator site closes or an investigator leaves the site.
2.12.14 Upon request of the monitor, auditor, IRB/IEC or regulatory authority, the investigator/institution should make available for direct access all requested trial- related records.
