Pages that link to "Glossary:TAG-00343-Doc-ten"

The following pages link to Glossary:TAG-00343-Doc-ten:

Displaying 50 items.

• Glossary (← links)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-001 (← links)
• Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.115 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter II Section 1.7 (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter I Section 1.8 (← links)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2.1 - Ende (← 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) Appendix C-001 (← links)
• Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3 (← links)
• Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.2 (← links)
• Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.3 (← links)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-001 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart G (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.27 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-002 (← links)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.10 (← links)
• Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 list of investigators (← links)
• Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 disclosure (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-001 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.5 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - informed consent (← 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:USA 21 CFR Part 50 09-Apr-2025 § 50.27 (← links)
• Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.117 (← links)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 III. (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section K No. 59-60 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40 Absatz 2 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33 Absatz 2 (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. ; 3. (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (i) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.2 (← links)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3 (← links)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3.2 (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.9 (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (a) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (2) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.1 - 2.12.3 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.8 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-002 (← links)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-002 (← links)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.7 (← links)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 7 (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 10. (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (b) (← links)