| | Scope | Document part | Language | Document |
|---|
| EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1 | G | Section 7
7.3.1 | EN | EU 2011/C 172/01 - CT-3 11-Jun-2011 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 57 – 59 | MD | Article 2
Paragraph 57 – 59 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 1-2 | MD | Article 80
Paragraph 1-2 | 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 2 Paragraph 60 – 62 | IVD | Article 2
Paragraph 60 – 62 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 1 | IVD | Article 76
Paragraph 1 | 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. 19 | HM | ANNEX I
Section D
No. 19 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1 | HM | ANNEX III
Section 2.1 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 32-34 | HM | Article 2
Paragraph 2
No. 32-34 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-001 | HM | Article 41 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-002 | HM | Article 41 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m) | HM | Article 2
(m) | EN | GBR Directive 2001/20/EC 04-Apr-2001 |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 adverse event adverse reaction | HM | Article 2
adverse event
adverse reaction | EN | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| ICH ICH E19 Guideline 2022 6 | G | 6 | EN | ICH ICH E19 Guideline 2022 |
| ICH ICH E6 Guideline R3 (2025) Appendix B 9.4 | G | Appendix B
9.4 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Event (AE) | G | GLOSSARY - Adverse Event (AE) | 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) |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.1 | MD | 3.1 | 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 3.2 | MD | 3.2 | 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 Annex F | MD | Annex F | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event | HM | § 312.32 - Adverse event | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse event | HM | § 312.32 - Life-threatening Adverse event | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) - | G | - | EN | USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) |
| USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation | G | Introduction ; III. B. ; Evaluation | EN | USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1. | G | 2.1.1. | EN | USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1 | G | 5.1 | EN | USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2 | G | 5.2 | EN | USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.1 | G | 5.3.1 | EN | USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2 | G | 5.3.2 | EN | USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1 | G | 5.6.6.1 | EN | USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.13 | HM | 5.13 | 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 - Committee | HM | 7.1 - Committee | 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 - Investigator | HM | 7.1 - Investigator | 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 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Sponsor | HM | 7.2 - Sponsor | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse event | HM | Glossary - adverse event | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
