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List of results

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