Glossary:TAG-00122-Aud-Aud

Glossary > Audit trail

Audit trail
Tag-ID	TAG-00122-Aud-Aud
English	Audit trail / Electronic audit trail / Data audit trail
French	Piste d'audit / Piste d'audit électronique / Traçabilité des modifications
German	Audit-Trail / Elektronischer Audit-Trail / Änderungsprotokoll

References

	Scope	Document part	Language	Document
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA	G	4.5 ALCOA	EN	EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT	G	4.5 CCEAT	EN	EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023
ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.3 - 4.2.4	G	III. Annex 1 4.2.3 - 4.2.4	EN	ICH ICH E6 Guideline R3 (2025)
USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4.	G	III 4.	EN	USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8	HM	8	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995