View source for Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT

{{ReferenceData
|has_document=Document:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023
|module=4
|unit=4.2.3
|scope=G
|doc_part=4.5
CCEAT
|language=EN
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00129-Dat-ali ++ TAG-00136-Met-ate ++ TAG-00122-Aud-Aud
|tags_display=[[Glossary:TAG-00129-Dat-ali|Data integrity]], [[Glossary:TAG-00136-Met-ate|Metadata]], [[Glossary:TAG-00122-Aud-Aud|Audit trail]]
|comment=ALCOA++ principles: completeness and data reconstruction
|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).
}}