| | Scope | Document part | Language | Document |
|---|
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 24 | HM | § 4
Absatz 24 | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 9 | NIS | Leitlinie 9 | DE | DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 |
| DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 7 | G | § 7 | DE | DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 |
| DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 8 | G | § 8 | DE | DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 48 | MD | § 48 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 53 | MD | § 53 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001 | MD | 8.2 | EN | EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 |
| EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002 | MD | 8.2 | EN | EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 |
| EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.2 | G | 3.2 | EN | EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 |
| EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-002 | G | 2.5 | EN | EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 |
| EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3 | G | 3 | EN | EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 6 – 7 | MD | Article 70
Paragraph 6 – 7 | 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 66 Paragraph 6 – 7 | IVD | Article 66
Paragraph 6 – 7 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 11 | G | Article 11 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 12 | G | Article 12 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 13 | G | Article 13 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 14 | G | Article 14 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 21 | HM | Article 21 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 22 | HM | Article 22 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 5 | G | Article 5 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 52 | HM | Article 52 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 54 | HM | Article 54 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 8 | G | Article 8 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 9 | G | Article 9 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notify | HM | D
Who should notify | EN | GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 |
| GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6 | MD | 5 - 6 | EN | GBR MEDDEV 2.7/3 revision 3 May-2015 |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 17 | HM | Article 17 | 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 Article 22-23 | HM | Article 22-23 | 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 Article 29A | HM | Article 29A | 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 Article 3 (1) - (5) | HM | Article 3
(1) - (5) | 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 Article 3 (6) - (11) | HM | Article 3
(6) - (11) | 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 Article 30-001 | HM | Article 30 | 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 Article 30-002 | HM | Article 30 | 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 Article 34 | HM | Article 34 | EN | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 3 | HM | Annex 2
3 | EN | ICH ICH E6 Guideline - Annex 2 R3 Annex 2 |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor | G | GLOSSARY - Sponsor | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor-Investigator | G | GLOSSARY - Sponsor-Investigator | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3 | G | III. Annex 1
3 | 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 E6 Guideline R3 (2025) III. Annex 1 3.13.1 | G | III. Annex 1
3.13.1 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.5 | G | III. Annex 1
3.5 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.6 | G | III. Annex 1
3.6 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.8 | G | III. Annex 1
3.8 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3 | G | III. Annex 1
3.9.3 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 4 | G | III. Annex 1
4 | EN | ICH ICH E6 Guideline R3 (2025) |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.2 | MD | 9.2.2 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor | HM | § 312.3
(b) - Sponsor | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor-Investigator | HM | § 312.3
(b) - Sponsor-Investigator | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.31 | HM | § 312.31 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.33 | HM | § 312.33 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) (3) | HM | § 312.33
(a) (3) | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.38 | HM | § 312.38 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.40 (c) (d) | HM | § 312.40
(c) (d) | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.50 | HM | § 312.50 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) | HM | § 312.53
(c) | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.64 (c) - (d) | HM | § 312.64
(c) - (d) | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (e) | G | § 50.3
(e) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (f) | G | § 50.3
(f) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 § 56.105 | G | § 56.105 | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (n) | MD | § 812.3
(n) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (o) | MD | § 812.3
(o) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.40 | MD | § 812.40 | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.45 | MD | § 812.45 | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.7 (c) | MD | § 812.7
(c) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.11 | HM | 4.11 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.17 | HM | 4.17 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Amendment | HM | 4.4 - Amendment | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard | HM | 4.4 - immediate hazard | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5 | HM | 5 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.6 | HM | 5.6 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - sponsor | HM | Glossary - sponsor | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WMA Declaration of Helsinki 2024 34 | G | 34 | EN | WMA Declaration of Helsinki 2024 |
