Pages that link to "Template:DocumentBox"

The following pages link to Template:DocumentBox:

Displaying 50 items.

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-001 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-001 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix C C.2.3 (transclusion) (← 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 (transclusion) (← 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 (transclusion) (← 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 3.5.3 (transclusion) (← 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 (transclusion) (← links)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5 (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-001 (transclusion) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart G (transclusion) (← links)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 22 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) II 7.4 (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2 (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Appendix 2 (transclusion) (← links)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - CIP (transclusion) (← links)
• Reference:N.A. SPIRIT 2013 - Chan et al. 2013 - (transclusion) (← links)
• Reference:ICH ICH E8 Guideline R1 (2021) 5. (transclusion) (← links)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary (transclusion) (← links)
• Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1. (transclusion) (← links)
• Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) - (transclusion) (← links)
• Reference:INT ISPE - GPP Revision 3 (2015) II. (transclusion) (← links)
• Reference:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3 (transclusion) (← links)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6) (transclusion) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.25 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator’s Brochure (IB) (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix A (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochure (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex B (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (5) (transclusion) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.27 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-002 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-002 (transclusion) (← links)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.10 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Contract Research Organisation (CRO) (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Service Provider (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor-Investigator (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3 (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - sponsor (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract research organization (CRO) (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.17 (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 2. ; 7. (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 2 (transclusion) (← links)