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Property:RefLanguage

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Showing 20 pages using this property.
I
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15 +
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ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.3 +
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ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g) +
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ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1 +
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ICH ICH E8 Guideline R1 (2021) 5.6 +
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ICH ICH E9 Guideline 1998 2.3 +
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ICH ICH E9 Guideline 1998 2.3.1 +
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ICH ICH E9 Guideline 1998 Glossary - Double-Dummy +
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W
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.2 +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Introduction +
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WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 31 +
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I
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.5 +
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ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - randomization +
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ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 (e) +
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E
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No.17 ; No. 22 +
EN  +
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section D No. 8 +
EN  +
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section 2.5 No. 17-22 +
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EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2 +
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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 - Randomisation +
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U
USA 21 CFR Part 314 09-Apr-2025 § 314.126 (4) - (5) +
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