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Showing 20 pages using this property.
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ICH ICH E6 Guideline R3 (2025) Appendix B 2.5 +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Introduction +
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WHO WHO - Guidance for best practices for clinical trials 2024 3.2.4 +
EN  +
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ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6 +
EN  +
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EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-003 +
EN  +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 6. +
EN  +
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USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii) +
EN  +
USA 21 CFR Part 812 09-Apr-2025 § 812.46 (a) +
EN  +
USA 21 CFR Part 812 09-Apr-2025 § 812.110 (b) +
EN  +
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ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.12 +
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ICH ICH E6 Guideline R3 (2025) Appendix B 12.3 +
EN  +
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USA 21 CFR Part 312 09-Apr-2025 § 312.70 +
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USA 21 CFR Part 812 09-Apr-2025 § 812.119 +
EN  +
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ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3 +
EN  +
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EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - ComCompliance +
EN  +
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GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 - +
EN  +
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EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 52 +
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EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.1 +
EN  +
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 6.4 +
EN  +
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.2 +
EN  +
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