Glossary:TAG-00043-Goo-tek

Glossary > Good clinical practice

Good clinical practice
Tag-ID	TAG-00043-Goo-tek
English	Good clinical practice
EN Abbr.	GCP
French	Bonnes pratiques cliniques / Bonnes pratiques de l'essai clinique
FR Abbr.	BPC
German	Gute klinische Praxis / Gute klinische Prüfungspraxis
DE Abbr.	GCP

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 4.3	G	4.3	EN	EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023
EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 5	G	5	EN	EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012
EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble Preamble	MD	Preamble	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 ANNEX XV Chapter III, 6	MD	ANNEX XV Chapter III, 6	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble Preamble	IVD	Preamble	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2	HM	Article 2	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-001	HM	Article 47	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-002	HM	Article 47	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-003	HM	Article 47	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble Preamble	HM	Preamble	EN	EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 28	HM	Article 28	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2	HM	Schedule 1 Part 2	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 10.	HM	Schedule 1 Part 2 10.	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 12.	HM	Schedule 1 Part 2 12.	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 7	HM	Schedule 1 Part 2 7	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E6 Guideline R3 (2025) I	G	I	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) II	G	II	EN	ICH ICH E6 Guideline R3 (2025)
INT ISPE - GPP Revision 3 (2015) -	INS	-	EN	INT ISPE - GPP Revision 3 (2015)
USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 -	MD	-	EN	USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018
USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 -	G	-	EN	USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018
USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 -	G	-	EN	USA Recognized Consensus Standards - ISO 14155 21-Dec-2020
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - Good Clinical Practice (GCP)	HM	Glossary - Good Clinical Practice (GCP)	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - validation	HM	Glossary - validation	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
WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 WHO Principles of GCP	G	WHO Principles of GCP	EN	WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005
WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 -	HM	-	EN	WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026