Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.1
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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 â Unit 4.2.5 |
| Scope | G |
| Document part | III. Annex 1
4.2.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Data capture tool, Metadata, Device system, Certified copy |
| Comment | Data life cycle: procedures and elements |
Content
4.2 Data Life Cycle Elements
Procedures should be in place to cover the full data life cycle.
4.2.1 Data Capture (a) When data captured on paper or in an electronic health record are manually transcribed into a computerised system (e.g., data acquisition tool), the need for and the extent of data verification should take the criticality of the data into account.
(b) Acquired data from any source, including data directly captured in a computerised system (e.g., data acquisition tool), should be accompanied by relevant metadata.
(c) At the point of data capture, automated data validation checks to raise data queries should be considered as required based on risk, and their implementation should be controlled and documented.
