Pages that link to "Glossary:TAG-00245-Spo-ten"

The following pages link to Glossary:TAG-00245-Spo-ten:

Displaying 50 items.

• Glossary (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-001 (← links)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.3 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5 (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 2. ; 7. (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 2 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b-002 (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (6) - (11) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.50 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.52 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.40 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.45 (← links)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI C. (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-002 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-001 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (5) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.6 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.4 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (b) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-003 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (a) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.12 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 57 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Paragraph 3 (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-001 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 48 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 2 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Section 4 (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 2 (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 4 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (d) (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-002 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.13 (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.5 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-002 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-003 (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4 (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 1 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-001 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40a Absatz 3 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.17.1 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.14 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.12 (← links)