Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Integrity
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| 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 | GLOSSARY - Data Integrity |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Data integrity, Source documents |
Content
Data Integrity Data integrity includes the degree to which data fulfil key criteria of being attributable, legible, contemporaneous, original, accurate, complete, secure and reliable such that data are fit for purpose.
