Pages that link to "Glossary:TAG-00329-Saf-lne"

The following pages link to Glossary:TAG-00329-Saf-lne:

Displaying 50 items.

• Glossary (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 34 (← links)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.1 (← links)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2. (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 82 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Institutional Review Board (IRB)/Independent Ethics Committee (IEC) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committee (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Introduction (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - IEC (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (t) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 & 4 (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 57 (← links)
• Reference:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107m (1) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.60-001 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64-001 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart E (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.1 (← links)
• Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A. (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.7 (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (k)-(l) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.60-002 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.100 (← links)
• Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. B. (← links)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 IV. (← links)
• Reference:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 - (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section 2.5 No. 17-22 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 51 (← links)
• Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 5.1 (← links)
• Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 4 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.3 - 3.11.4.6 (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.4 (← 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) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 2 (← links)
• Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 11 d) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Amendment (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 13 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 75 (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 71 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 55 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 79 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.1 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) (← links)
• Reference:ICH ICH E2A Guideline 1994 III A. 2. (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (s) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) - (d) (← links)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.4 - 2.5 (← links)