Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT
From GxPlex
| Document information | |
|---|---|
| Reference | EU EMA/INS/GCP/112288/2023
- Guideline on computerised systems and electronic data in clinical trials 2023 |
| Validity area | EU |
| Scope(s) | G |
| Document name | EMA/INS/GCP/112288/2023
- Guideline on computerised systems and electronic data in clinical trials |
| Version / Revision | 2023 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | EMA/INS/GCP/112288/2023
Good Clinical Practice Inspectors Working Group (GCP IWG) Guideline on computerised systems and electronic data in clinical trials |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 â Unit 4.2.3 |
| Scope | G |
| Document part | 4.5
CCEAT |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Data integrity, Metadata, Audit trail |
Content
4.5. ALCOA++ principles [...] Complete To reconstruct and fully understand an event, data should be a complete representation of the observation made. This includes the associated metadata and audit trail and may require preserving the original context.
Consistent Processes should be in place to ensure consistency of the definition, generation/capturing and management (including migration) of data throughout the data life cycle. Processes should be implemented to detect and/or avoid contradictions, e.g. by the use of standardisation, data validation and appropriate training.
Enduring Data should be maintained appropriately such that they remain intact and durable through the entire data life cycle, as appropriate, according to regulatory retention requirements (see sections 6.8. and 6.10. on back-up and archiving).
Available when needed Data should be stored throughout the data life cycle and should be readily available for review when needed.
Traceable Data should be traceable throughout the data life cycle. Any changes to the data, to the context/metadata should be traceable, should not obscure the original information and should be explained, if necessary. Changes should be documented as part of the metadata (e.g. audit trail).
