Glossary:TAG-00033-Pro-oto

Glossary > Protocol

Protocol
Tag-ID	TAG-00033-Pro-oto
English	Protocol / Study protocol / Trial protocol
French	Protocole / Protocole d'étude / Protocole de l'essai
German	Prüfplan / Studienprotokoll / Prüfprotokoll

References

	Scope	Document part	Language	Document
CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 20	G	Page 20	EN	CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3	NIS	Leitlinie 3	DE	DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.10	NIS	Leitlinie 3 3.10	DE	DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107n	NIS	Article 107n	EN	EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12
EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary	HM	Glossary	EN	EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022
EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3	INS	3	EN	EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023)
EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) -	NIS	-	EN	EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)
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 ANNEX I Section D No.17 ; No. 22	HM	ANNEX I Section D No.17 ; No. 22	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section K No. 59-60	HM	ANNEX I Section K No. 59-60	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) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1.	G	Annex III 1.	EN	EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 6.	HM	Schedule 1 Part 2 6.	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E6 Guideline R3 (2025) Appendix B	G	Appendix B	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B 12.3	G	Appendix B 12.3	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B 14.3	G	Appendix B 14.3	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B 16	G	Appendix B 16	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B 2.5	G	Appendix B 2.5	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001	G	Appendix B 4.8	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-002	G	Appendix B 4.8	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B 6-001	G	Appendix B 6	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B 6-002	G	Appendix B 6	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B 8	G	Appendix B 8	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Protocol Amendment	G	GLOSSARY - Protocol Amendment	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) II 7.4	G	II 7.4	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.4.2	G	III. Annex 1 2.4.2	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5	G	III. Annex 1 2.5	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.1.4	G	III. Annex 1 3.1.4	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E8 Guideline R1 (2021) 5.	HM	5.	EN	ICH ICH E8 Guideline R1 (2021)
ICH ICH E8 Guideline R1 (2021) 6.2.2	HM	6.2.2	EN	ICH ICH E8 Guideline R1 (2021)
ICH ICH E8 Guideline R1 (2021) 7	G	7	EN	ICH ICH E8 Guideline R1 (2021)
ICH ICH E9 Guideline 1998 Glossary - Dropout	HM	Glossary - Dropout	EN	ICH ICH E9 Guideline 1998
INT ISPE - GPP Revision 3 (2015) II.	INS	II.	EN	INT ISPE - GPP Revision 3 (2015)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001	MD	Annex A A.6.3	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 Annex A A.6.3-002	MD	Annex A A.6.3	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
N.A. SPIRIT 2013 - Chan et al. 2013 -	G	-	EN	N.A. SPIRIT 2013 - Chan et al. 2013
USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (d)	HM	§ 312.23 (6) (d)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6)	HM	§ 312.23 (a) ; (6)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.30	HM	§ 312.30	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi)	HM	§ 312.53 (c) (vi)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii)	HM	§ 312.53 (c) (vi) - (vii)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.25	MD	§ 812.25	EN	USA 21 CFR Part 812 09-Apr-2025
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
WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Platform, basket and umbrella trials	G	1.1 - Platform, basket and umbrella trials	EN	WHO WHO - Guidance for best practices for clinical trials 2024
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2	HM	2	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.1	HM	9.1	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.3	HM	9.3	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Appendix 2	HM	Appendix 2	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - case -report form (CRF)	HM	Glossary - case -report form (CRF)	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol	HM	Glossary - protocol	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process	HM	Overview of the Clinical Research Process	EN	WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005
WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29	G	Page 28-29	EN	WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005
WMA Declaration of Helsinki 2024 Paragraph 22	G	Paragraph 22	EN	WMA Declaration of Helsinki 2024