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並前往https://www.ema.europa.eu/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-annex-i-definitions-rev-3-superseded_en.pdf

Guideline on good pharmacovigilance practices (GVP) - Annex I

EMA/876333/2011 Rev 3 (superseded version). Page 12/24. Individual case safety report (ICSR); synonym: Adverse (drug) reaction report.

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