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- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (a) - (b) ; (d) - (f) +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.13 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Sponsor +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Sponsor +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Independent Data Monitoring Committee (IDMC) +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9 +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 8 +
- Reference:ICH ICH E9 Guideline 1998 Glossary - IDMC +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Committee +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 13 +
- Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 78 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.5 +
- Reference:ICH ICH E2F Guideline 2010 1 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (c) +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-002 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 42 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 43 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 53 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 1, 3 & 4 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 1-2 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 3 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 4 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 5 – 6 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 1 – 2 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 3 – 5 +
- Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 1 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 73 Paragraph 1, 3, 4 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 2 – 3 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 4 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 5 – 6 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 82 Paragraph 3 – 5 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-002 +
