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Property:RefLanguage

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Showing 20 pages using this property.
E
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6 +
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EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13 +
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USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6) +
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USA 21 CFR Part 11 09-Apr-2025 § 11.10 +
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USA 21 CFR Part 11 09-Apr-2025 § 11.30 +
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USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m) +
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USA 45 CFR Part 160 09-Apr-2025 - +
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USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II +
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USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4. +
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ICH ICH E6 Guideline R3 (2025) GLOSSARY - Signature +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Part 1 Article 2 +
EN  +
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EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 Article 3 Paragraph 10 +
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EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 - +
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EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14 +
EN  +
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8 +
EN  +
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GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 - +
EN  +
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USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (5) ; (b) (7) ; (b) (8) +
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USA 21 CFR Part 11 09-Apr-2025 § 11.50 +
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USA 21 CFR Part 11 09-Apr-2025 § 11.70 +
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USA 21 CFR Part 11 09-Apr-2025 § 11.100 +
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