見読性とは

見読（けんどく）性という用語も日常生活では全く使用しないでしょう。
見読性とは何かというと、電磁的記録（電子記録）は、紙の記録と違って、直接人の目で読むことができません。
したがって紙媒体で保存する場合に比べて、電磁的記録で保存する場合は、何らかの方法で人が読める形で出力できる方策をあわせ備えておかなければなりません。
日本版ER/ES指針が求めているのは、以下の3つの形式で出力できることです。

  • ディスプレイ装置への表示ができること
  • 紙への印刷ができること
  • 電磁的認録媒体へのコピーができること
    ここで注意が必要なことは、例えディスプレイや紙に出力したとしても、0や1といったコンピュータの管理する記号で表示したのでは意味がわかりません。
    FDAは、見読性に相当する用語として、Legibleという用語をあてています。その要件は「データを見て適切なアクションが起こせるよう、判別できること」です。すなわち、「男」「女」や「入院」「外来」というように、意味がわかるように出力しなければならないということです。
    もうひとつ、よくある誤解は「3.電磁的認録媒体へのコピー」です。
    この電磁的認録媒体へのコピーを、データベースのダンプと理解している人がいますが、間違いです。
    規制当局が求めているのは、紙に出力するのと同様のフォーマットでCD-Rなどに出力することです。
    つまりpdf等でコピーするということです。
    もちろんExcelやWordなどのフォーマットでも良いでしょう。
    SASも認められるかも知れません。
    見読性は、かならずそれらの電磁的記録を表示する方策が伴わないといけないからです。
    上記のようなフォーマットであれば、規制当局が電磁的記録を持ち帰った際に「データを見て適切なアクションが起こせるよう、判別できる」でしょう。

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