| | Scope | Document part | Language | Document |
|---|
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 25 | HM | § 4
Absatz 25 | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 30-001 | MD | § 30 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 30-002 | MD | § 30 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| 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 Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 7 – 8 | IVD | Article 58
Paragraph 7 – 8 | 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 49 | HM | Article 49 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (d) | HM | Article 15
(5) (d) | 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 2 investigator | HM | Article 2
investigator | EN | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator | G | GLOSSARY - Investigator | 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 2 | G | III. Annex 1
2 | EN | ICH ICH E6 Guideline R3 (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 § 312.3 - Investigator | HM | § 312.3 - Investigator | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.53 | HM | § 312.53 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.70 | HM | § 312.70 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (d) | G | § 50.3
(d) | 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 54 09-Apr-2025 § 54.4 disclosure | G | § 54.4
disclosure | EN | USA 21 CFR Part 54 09-Apr-2025 |
| USA 21 CFR Part 54 09-Apr-2025 § 54.4 list of investigators | G | § 54.4
list of investigators | EN | USA 21 CFR Part 54 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 § 56.109 | G | § 56.109 | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.119 | MD | § 812.119 | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (i) | MD | § 812.3
(i) | 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 § 812.43 | MD | § 812.43 | EN | USA 21 CFR Part 812 09-Apr-2025 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 1.4 | HM | 1.4 | 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 4.2 | HM | 4.2 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator | HM | Glossary - investigator | 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 |
