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List of results
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 7 – 8 + (2.3.2)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 1.12 + (2.3.2)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-001 + (2.3.2)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 5 – 6 + (2.3.2)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 30-002 + (2.3.2)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-001 + (2.3.2)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 65 + (2.3.2)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (viii) + (2.3.2)
- Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A. + (2.3.2)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.2 + (2.3.3)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.7 + (2.3.3)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.3 + (2.3.3)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 50 + (2.3.3)
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.9 + (2.3.3)
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.4 + (2.3.3)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (d) + (2.3.3)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. + (2.3.3)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.5 + (2.3.4)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Agreement + (2.3.4)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.6 + (2.3.4)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.14-001 + (2.3.4)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract + (2.3.4)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.11 + (2.3.4)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.9 + (2.3.4)
- Reference:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 33 + (2.3.4)
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.7 + (2.3.4)
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 9 + (2.3.4)
- Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1121-3-1 + (2.3.4)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (k)-(l) + (2.3.4)
- Reference:GBR IRAS - Integrated Research Application System 28-Jan-2025 Templates + (2.3.4)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) + (2.3.4)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (5) + (2.3.4)
- Reference:WMA Declaration of Helsinki 2024 Paragraph 9 + (2.4.0)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-001 + (2.4.0)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - escape treatment + (2.4.0)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.1 + (2.4.0)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 + (2.4.0)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1 (f) + (2.4.0)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4 (j) + (2.4.0)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5 (j) + (2.4.0)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 7 + (2.4.0)
- Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-001 + (2.4.0)
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.25 (e) + (2.4.0)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.60-002 + (2.4.0)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.100 + (2.4.0)
- Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. B. + (2.4.0)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Informed Consent + (3.1.1)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8 + (3.1.1)
- Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.2 + (3.1.1)
- Reference:WMA Declaration of Helsinki 2024 Paragraph 25 – 28 + (3.1.1)
- Reference:WMA Declaration of Helsinki 2024 Paragraph 31 – 32 + (3.1.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - informed consent + (3.1.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - witness + (3.1.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c) ; e) - g) + (3.1.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.5 + (3.1.1)
- Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 60-61 + (3.1.1)
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 Annex 2 2.5 + (3.1.1)
- Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 23 + (3.1.1)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.2 + (3.1.1)
- Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4. + (3.1.1)
- Reference:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6 + (3.1.1)
- Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3 + (3.1.1)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1 + (3.1.1)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 2-3 + (3.1.1)
