Glossary:TAG-00129-Dat-ali

Glossary > Data integrity

Data integrity
Tag-ID	TAG-00129-Dat-ali
English	Data integrity / Data quality / Data reliability
French	Intégrité des données / Qualité des données / Fiabilité des données
German	Datenintegrität / Datenqualität / Datenzuverlässigkeit

References

	Scope	Document part	Language	Document
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4	G	4.4	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 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
EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011 4	G	4	EN	EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-001	MD	Article 72 Paragraph 3 – 4	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-001	IVD	Article 68 Paragraph 3 – 4	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 Introduction	G	Annex 2 Introduction	EN	ICH ICH E6 Guideline - Annex 2 R3 Annex 2
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Integrity	G	GLOSSARY - Data Integrity	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.1 - 2.12.3	G	III. Annex 1 2.12.1 - 2.12.3	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.5 – 2.12.9	G	III. Annex 1 2.12.5 – 2.12.9	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g)	G	III. Annex 1 3.16.1 (g)	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution	G	III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 4	G	III. Annex 1 4	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1	G	III. Annex 1 4.1	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.3	G	III. Annex 1 4.3.3	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E8 Guideline R1 (2021) 6.1.4	HM	6.1.4	EN	ICH ICH E8 Guideline R1 (2021)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.8	MD	7.8	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II	G	II	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 - Introduction	HM	8 - Introduction	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - verification (validation) of data	HM	Glossary - verification (validation) of data	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 94	G	Page 94	EN	WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005