Glossary:TAG-00150-Sou-eUr

Glossary > Source documents

Source documents
Tag-ID	TAG-00150-Sou-eUr
English	Source records / Source data / Source documents
French	Données sources / Documents sources / Données de base / Données originales
German	Quelldaten / Quelldokumente / Ursprungsdaten / Primärdaten

References

	Scope	Document part	Language	Document
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2	NIS	2.2	DE	DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022
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/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - SD	G	3.1.2 - SD	EN	EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023
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) GLOSSARY - Source Records	G	GLOSSARY - Source Records	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)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.47	MD	3.47	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.48	MD	3.48	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.3	MD	7.5.3	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
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 - Computerized Systems Used in Clinical Investigations May-2007 IV	G	IV	EN	USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007
USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 III	G	III	EN	USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015
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
USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 2.	G	III 2.	EN	USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013
USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - CRF	G	Page 3 - CRF	EN	USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025
USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - Note	G	Page 3 - Note	EN	USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - patient/subject file	HM	Glossary - patient/subject file	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - raw data	HM	Glossary - raw data	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995