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。

https://www.youtube.com/watch?v=seajT5g7clk

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  554. Con chim yến tiết nước dãi, khi tiếp xúc với không khí nước dãi chim yến sẽ đông cứng lại, cứ như vậy tạo thành tổ yến.

  555. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. Aenean commodo ligula eget dolor. Aenean massa. Cum sociis natoque penatibus et magnis dis parturient montes, nascetur ridiculus mus. Donec quam felis, ultricies nec, pellentesque eu, pretium quis, sem.

  556. The device can be used as a magnetic stud finder,

  557. Gaming requires power and is very exerting for gaming laptops. Both the CPU and GPU must work to their maximum capacity. And these components are mostly under stress which often leads to overheating. However, a little bit of overheating is standard as your laptop is running at optimal. But it must not surpass acceptable levels. Excessive overheating of gaming laptops can cause damage to your hardware.

  558. This strong magnet is also completely waterproof and maintains its strength over time.

  559. धैर्य एवं संयम में विश्वास करता है। सफलता एक दिन की मेहनत का प्रतिफल नहीं

  560. open detail page in the another website select “Other website link”

  561. Despite its small size, MagnetPAL is capable of safely holding up to 100 times its own weight

  562. Tổ của chim yến được làm từ nước dãi của loài chim này, có hình dạng như chén trà bổ đôi, trũng lòng ở giữa.

  563. The device has a tough plastic housing that makes it ideal for use in the workplace,

  564. You might have a big set up planned for a right hook, but be flexible

  565. whichperhaps makes all of them swoon over Westerners.

  566. Trụ sở chính của Oettinger nằm ở Oettingen ở Bayern nhưng cũng có các nhà máy bia ở Gotha

  567. If you want to open detail page in the same website select detail page

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  569. Ah, so you read on purely to see pretty pictures of fish. If you paid for that privilege, they’d call it OnlyFins.

  570. build a purposeful as well as enduring partnership.

  571. के कारणों का समुचित आकलन कर पुनः दुगने उत्साह से प्रयास करते हैं।

  572. But if being a farmer or running a remote team makes you happiest, then you should do that.

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  574. fancy and possesses a swarm of confidence. But why not!?

  575. leading safety procedures as well as an ever-growing neighborhood.

  576. Trong các loại bia phải kể đến một dòng bia hàng đầu đó là dòng bia Oettinger Brauerei.

  577. It should bring you enough ROI and value to justify the rest of the year of jabs

  578. The Latest Laptop deals | HP, Lenovo, MSI

  579. Dubbed ‘Muhammad Sanusi II: An Icon of Reforms’, the gathering, with an impressive roll call of politicians, monarchs,

  580. They also offer state-of-the-art procedures of interaction amongst members,

  581. Hương thơm và sự ngọt ngào đọng lại đã quyến rũ tất cả những người sành bia khi nâng ly thưởng thức bia Đức.

  582. I’ve had to change and shift multiple times to match what is happening in the marketplace

  583. Untuk dapat membedakan serta memahami lebih lanjut, berikut pembahasan mengenai adverb serta adjective.

  584. VYou also do not must fear rejection due to the fact that you actually have

  585. Nó được xem như là một thứ đồ uống hữu hiệu, xua tan cơn khát và sự thèm muốn.

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  588. my entire business philosophy pretty much revolves around the jab jab jab right hook method

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