Pages that link to "Glossary:TAG-00112-Ass-nve"

The following pages link to Glossary:TAG-00112-Ass-nve:

Displaying 18 items.

• Glossary (← links)
• Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4. (← links)
• Reference:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 4 – 6 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 1.2.7 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.12 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.13 (← links)
• Reference:ICH ICH E11 Guideline R1 (2017) 8 (← links)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 29 – 30 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 1 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 2-3 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 65 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 3 (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 4 (← links)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (n) (← links)
• Reference:USA 21 CFR Part 50 09-Apr-2025 Subpart D (← links)
• Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart D (← links)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 V. (← links)