Pages that link to "Glossary:TAG-00150-Sou-eUr"

The following pages link to Glossary:TAG-00150-Sou-eUr:

Displaying 33 items.

• Glossary (← links)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2 (← 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 5.1 - 5.2-001 (← 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:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.4 (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Integrity (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Source Records (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.1 - 2.12.3 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.5 – 2.12.9 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - patient/subject file (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - raw data (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.47 (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.48 (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.3 (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.8 (← 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 5.1 - 5.2-002 (← links)
• Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - SD (← links)
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 2. (← links)
• Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 III (← links)
• Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV (← links)
• Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - CRF (← links)
• Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - Note (← links)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4 (← links)
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II (← links)
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4. (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.3 - 4.2.4 (← links)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III B. 3. (← links)
• Reference:AUT FAQ - COVID-19 Studien 15-Mar-2021 - (← links)
• Reference:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 Q15 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11.2 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix C 2 (← links)