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Glossary:TAG-00143-Non-abw

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Glossary > Protocol deviation

Protocol deviation
Tag-ID TAG-00143-Non-abw
English Noncompliance / Protocol deviation / Protocol violation
French Non-conformité / Déviation au protocole / Violation du protocole
German NichtkonformitÀt / Protokollabweichung / Protokollverletzung

References

 ScopeDocument partLanguageDocument
ICH ICH E6 Guideline R3 (2025) Appendix B 12.3GAppendix B 12.3ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.12GIII. Annex 1 3.12ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3GIII. Annex 1 3.9.3ENICH ICH E6 Guideline R3 (2025)
USA 21 CFR Part 312 09-Apr-2025 § 312.70HM§ 312.70ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.119MD§ 812.119ENUSA 21 CFR Part 812 09-Apr-2025
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