Glossary:TAG-00137-Mon-che

Glossary > Monitoring

Monitoring
Tag-ID	TAG-00137-Mon-che
English	Monitoring / Clinical monitoring / On-site monitoring
French	Surveillance / Monitoring / Monitoring clinique / Monitoring sur site
German	Monitoring / Überwachung / Klinisches Monitoring / Studienmonitoring

References

	Scope	Document part	Language	Document
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Monitoring	G	3.1.2 - Monitoring	EN	EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4	HM	4.4	EN	EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 2	MD	Article 72 Pragraph 2	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 2	IVD	Article 68 Paragraph 2	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 17	HM	ANNEX I Section D No. 17	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 48	HM	Article 48	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
ICH ICH E19 Guideline 2022 6	G	6	EN	ICH ICH E19 Guideline 2022
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.1 - 3.11.4.2	G	III. Annex 1 3.11.4 3.11.4.1 - 3.11.4.2	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.3 - 3.11.4.6	G	III. Annex 1 3.11.4 3.11.4.3 - 3.11.4.6	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.3	G	III. Annex 1 3.11.4.5.3	EN	ICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.4	MD	9.2.4	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b)	MD	§ 812.46 (b)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-001	MD	§ 812.46 (b) - (c)	EN	USA 21 CFR Part 812 09-Apr-2025
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III - IV.	G	III - IV.	EN	USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A.	G	IV A.	EN	USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence	G	IV A. Adherence	EN	USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct	G	IV A. Conduct	EN	USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Verification	G	IV A. Verification	EN	USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI C.	G	VI C.	EN	USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI D.	G	VI D.	EN	USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-001	HM	4.12	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6	HM	6	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Sponsor	HM	7.1 - Sponsor	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WMA Declaration of Helsinki 2024 Paragraph 23 - Oversight	G	Paragraph 23 - Oversight	EN	WMA Declaration of Helsinki 2024