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Showing 20 pages using this property.
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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 +
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EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5 +
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USA 21 CFR Part 312 09-Apr-2025 § 312.62 +
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USA 21 CFR Part 312 09-Apr-2025 § 312.57-001 +
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USA 21 CFR Part 812 09-Apr-2025 Subpart G +
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WMA Declaration of Helsinki 2024 Paragraph 22 +
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ICH ICH E6 Guideline R3 (2025) Appendix B +
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ICH ICH E6 Guideline R3 (2025) II 7.4 +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2 +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Appendix 2 +
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WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29 +
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ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - CIP +
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N.A. SPIRIT 2013 - Chan et al. 2013 - +
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ICH ICH E8 Guideline R1 (2021) 5. +
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EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary +
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EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1. +
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EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) - +
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INT ISPE - GPP Revision 3 (2015) II. +
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EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3 +
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