| | Scope | Document part | Language | Document |
|---|
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section D No. 8 | HM | ANNEX VI
Section D
No. 8 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Blinding/Masking | G | GLOSSARY - Blinding/Masking | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.3 | G | III. Annex 1
2.9.3 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15 | G | III. Annex 1
3.15 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g) | G | III. Annex 1
3.16.1
(g) | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1 | G | III. Annex 1
4.1 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E8 Guideline R1 (2021) 5.6 | HM | 5.6 | EN | ICH ICH E8 Guideline R1 (2021) |
| ICH ICH E9 Guideline 1998 2.3 | HM | 2.3 | EN | ICH ICH E9 Guideline 1998 |
| ICH ICH E9 Guideline 1998 Glossary - Double-Dummy | HM | Glossary - Double-Dummy | EN | ICH ICH E9 Guideline 1998 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 (e) | MD | 10.7
(e) | 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 3.5 | MD | 3.5 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| USA 21 CFR Part 314 09-Apr-2025 § 314.126 (4) - (5) | HM | § 314.126
(4) - (5) | EN | USA 21 CFR Part 314 09-Apr-2025 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Introduction | HM | 8 - Introduction | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.2 | HM | 9.2 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |