データインテグリティとは

昨今、製薬企業や医療機器企業ではデータインテグリティに関する関心が高まっている。
データインテグリティを本邦では「データの完全性」と訳しているケースが多い。
しかしながら筆者はこの訳に違和感を感じている。

データインテグリティを構成する要素には以下の4つがある。

  1. Complete
  2. Accurate
  3. Consistent
  4. Secure

である。(図参照)
まずCompleteが完全性である。つまり完全性はデータインテグリティの一つであるがすべてではないのである。
次にAccurateは正確性である。データの正確性を証明するのはそう容易くはない。
例えば、使用した分析機器が適切に点検、校正されていたか。試薬の有効期限が切れていなかったか、また試薬の種類や量を間違わなかったか。分析結果の転記ミスはなかったか。また計算ミスはなかったか。などである。果たしてこれらを第三者が 客観的に確認できる記録が残されているだろうか。
Consistentは一貫性である。一貫性とは更新された2つのデータレコードの間における、あらゆるデータの変更や改ざんがないことである。データの再現性やトレーサビリティが重要となる。
Secureはセキュリティで保護されている状態である。故意か事故かに関わらずデータが消失したり意図しない変更を加えられてはならない。

データインテグリティというとすぐにデータの不正を連想する人が多い。そうではないのである。
事故であれ、故意であれ、データが意図せず変更(改ざん)されてしまっては患者の安全性が担保できないのである。
つまり改ざんによってデータが変更された事象と、不注意でデータが変更されて事象では、患者に対する影響は同じなのである。
実は、手順書の不備(チェックの不備)や教育訓練の不徹底などによるデータインテグリティ違反は全体の80%にものぼる。手順書の改訂やデータインテグリティに関する教育の徹底が望まれる。
また​データインテグリティのセミナーなどでは、Part11を引き合いに電子記録を中心に解説されていることが多い。筆者はこれにも違和感を感じている。
データインテグリティは、紙媒体にも電子記録にも等しく適用される。
紙媒体のデータインテグリティ違反と電子記録のデータインテグリティ違反では、どちらも患者に対する健康被害は同じであるからである。

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