| | Scope | Document part | Language | Document |
|---|
| DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 11 | NIS | Leitlinie 11 | DE | DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 |
| EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2. | HM | 2. | EN | EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 | MD | Article 62
Paragraph 3 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 & 4 | MD | Article 62
Paragraph 3 & 4 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 82 | MD | Article 82 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 53 | HM | Article 53 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-001 | HM | Article 10
(b) | EN | GBR Directive 2001/20/EC 04-Apr-2001 |
| GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-002 | HM | Article 10
(b) | EN | GBR Directive 2001/20/EC 04-Apr-2001 |
| ICH ICH E2A Guideline 1994 III A. 2. | G | III A. 2. | EN | ICH ICH E2A Guideline 1994 |
| ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.4 - 2.5 | G | Annex 2
2.4 - 2.5 | EN | ICH ICH E6 Guideline - Annex 2 R3 Annex 2 |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) | G | III. Annex 1
2.7.2
(a) | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) - (d) | G | III. Annex 1
2.7.2
(a) - (d) | 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 3.13.2 (a) - (b) ; (d) - (f) | G | III. Annex 1
3.13.2
(a) - (b) ; (d) - (f) | EN | ICH ICH E6 Guideline R3 (2025) |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.5 | MD | 9.2.5 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.3 - IEC | HM | § 312.3 - IEC | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.32 (b) | HM | § 312.32
(b) | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.32 (d) | HM | § 312.32
(d) | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.42 | HM | § 312.42 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.60-001 | HM | § 312.60 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.60-002 | HM | § 312.60 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 Subpart E | MD | Subpart E | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.100 | MD | § 812.100 | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. B. | G | III. B. | EN | USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committee | HM | Glossary - ethics committee | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
