| | 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 |
