Pages that link to "Glossary:TAG-00069-Imm-rhe"

The following pages link to Glossary:TAG-00069-Imm-rhe:

Displaying 27 items.

• Glossary (← links)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.23 (← links)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.24 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.8 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) II 2.4 (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.3 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 1 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 2-3 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 68 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 5 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse event (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21. (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 53 (← links)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001 (← links)
• Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-001 (← links)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002 (← links)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.1 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-001 (← links)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-001 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 (b) (ii) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.46 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 54 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 6 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 66 (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-002 (← links)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-002 (← links)