Pages that link to "Glossary:TAG-00066-Cau-enh"

The following pages link to Glossary:TAG-00066-Cau-enh:

Displaying 16 items.

• Glossary (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Event (AE) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse event (← links)
• Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1 (← links)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Drug Reaction (ADR) (← links)
• Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.2 (← links)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 8 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2 (← links)
• Reference:ICH ICH E2A Guideline 1994 III A. 1. (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (b) (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 3 – 5 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1 (← links)