Pages that link to "Glossary:TAG-00011-Inv-tud"

The following pages link to Glossary:TAG-00011-Inv-tud:

Displaying 50 items.

• Glossary (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B. B4 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 2 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 3 (← links)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (a) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.21 (← links)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2. (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (d) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (b) (← 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:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (5) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor-Investigator (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (viii) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-001 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (c) - (d) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigational Product (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigational product (synonym: study product) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.10 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.3 (← 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: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 10.3 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.4 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 51 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 66 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 68 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 69 (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigational medicinal product (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 7 Part 2 2. (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 12. (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.6 - §312.8 ; § 312.10 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (c) (d) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (b) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.61 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.69 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.31 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Drug Reaction (ADR) (← links)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (n) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction (← links)
• Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV. (← links)
• Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; IV. (← links)