「U.S. FDA, Guidance for Industry, “Use of Electronic Health Record Data in Clinical Investigations”, 2018,」他EMA(3件)の和訳を追加いたしました。

和訳追加
・U.S. FDA, Guidance for Industry, “Use of Electronic Health Record Data in Clinical Investigations”, 2018,
・EMA, “Notice to sponsors on validation and qualification of computerised systems used in clinical trials”, 2020 [和訳付]
・EMA, “Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)”, 2018 [和訳付]
・EMA, “Q&A: Good clinical practice (GCP)” #8 & #9, 2020 [和訳付]

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