Pages that link to "Glossary:TAG-00250-Inv-sme"

The following pages link to Glossary:TAG-00250-Inv-sme:

Displaying 30 items.

• Glossary (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64-001 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 65 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (5) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 19 (← links)
• Reference:ICH ICH E19 Guideline 2022 6 (← 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: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)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.10 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Investigator (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.8 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-001 (← links)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001 (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 32 (← links)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 16 (← links)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002 (← links)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.2 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (b) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (1) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.13 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-002 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 63 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (4) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (2) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64-002 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (3) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (c) - (d) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (6) (← links)