| | Scope | Document part | Language | Document |
|---|
| EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Monitoring | G | 3.1.2 - Monitoring | EN | EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 |
| EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4 | HM | 4.4 | 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 72 Pragraph 2 | MD | Article 72
Pragraph 2 | 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 68 Paragraph 2 | IVD | Article 68
Paragraph 2 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| 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 Article 48 | HM | Article 48 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| ICH ICH E19 Guideline 2022 6 | G | 6 | EN | ICH ICH E19 Guideline 2022 |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.1 - 3.11.4.2 | G | III. Annex 1
3.11.4
3.11.4.1 - 3.11.4.2 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.3 - 3.11.4.6 | G | III. Annex 1
3.11.4
3.11.4.3 - 3.11.4.6 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.3 | G | III. Annex 1
3.11.4.5.3 | EN | ICH ICH E6 Guideline R3 (2025) |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.4 | MD | 9.2.4 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) | MD | § 812.46
(b) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-001 | MD | § 812.46
(b) - (c) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III - IV. | G | III - IV. | EN | USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. | G | IV A. | EN | USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence | G | IV A. Adherence | EN | USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct | G | IV A. Conduct | EN | USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Verification | G | IV A. Verification | EN | USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI C. | G | VI C. | EN | USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI D. | G | VI D. | EN | USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-001 | HM | 4.12 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6 | HM | 6 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Sponsor | HM | 7.1 - Sponsor | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WMA Declaration of Helsinki 2024 Paragraph 23 - Oversight | G | Paragraph 23 - Oversight | EN | WMA Declaration of Helsinki 2024 |
