Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.5 – 2.12.9
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
2.12.5 – 2.12.9 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Case report form, Data integrity, Investigator responsibilities, Serious adverse event, Source documents |
Content
2.12.5 The investigator should ensure the accuracy, completeness, legibility and timeliness of the data reported to the sponsor in the data acquisition tools completed by the investigator site (e.g., case report form (CRF)) and in any other required reports (e.g., SAE reports). The investigator should review and endorse the reported data at important milestones agreed upon with the sponsor (e.g., interim analysis) (see section 3.16.1(o)).
2.12.6 Data reported to the sponsor should be consistent with the source records or the discrepancies explained. Changes or corrections in the reported data should be traceable, should be explained (if necessary) and should not obscure the original entry.
2.12.7 The investigator/institution should implement appropriate measures to protect the privacy and confidentiality of personal information of trial participants in accordance with applicable regulatory requirements on personal data protection.
2.12.8 Data reported to the sponsor should be identified by an unambiguous participant code that can be traced back to the identity of the participant by the investigator/institution.
2.12.9 For systems deployed by the investigator/institution that maintain and retain trial data/information, the investigator/institution should ensure that such data are protected from unauthorised access, disclosure, dissemination or alteration and from inappropriate destruction or accidental loss.
