Pages that link to "Glossary:TAG-00033-Pro-oto"

The following pages link to Glossary:TAG-00033-Pro-oto:

Displaying 50 items.

• Glossary (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B. B4 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 1 – 2 (← links)
• Reference:ICH ICH E8 Guideline R1 (2021) 3.3.5 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.1 (← links)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (d) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.3 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-001 (← links)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23 (← links)
• Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 20 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Consultation (← links)
• Reference:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107n (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 3 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 39 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 50 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (← 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:WMA Declaration of Helsinki 2024 Paragraph 22 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) II 7.4 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Appendix 2 (← links)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29 (← links)
• Reference:N.A. SPIRIT 2013 - Chan et al. 2013 - (← links)
• Reference:ICH ICH E8 Guideline R1 (2021) 5. (← links)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary (← links)
• Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1. (← links)
• Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) - (← links)
• Reference:INT ISPE - GPP Revision 3 (2015) II. (← links)
• Reference:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3 (← links)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.25 (← links)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.10 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-002 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Agreement (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.11 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.5 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.1 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.4.2 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.3 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section K No. 59-60 (← links)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q5.2 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33 Absatz 2 (← links)
• Reference:ICH ICH E8 Guideline R1 (2021) 7 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 5 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-001 (← links)