データインテグリティの誤解

昨今、製薬業界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。
しかしである。多くの企業や、講演・書籍を執筆しているコンサルテントに至るまで適切にデータインテグリティを理解している人は少ないと思われる。

誤解その1 不正
データインテグリティは、不正や改ざんに焦点を当てているケースが多いと見受けられる。
データインテグリティが焦点を当てるべきは不正や改ざんのみではないのである。
例えば、故意に変更したデータと、事故(不注意)によって変更されてしまったデータがあったとしよう。
どちらの方が患者の安全性にとって重大であろうか。
両者は全く同じである
そもそも、製薬業界においてそんなに不正や改ざんが多く日常茶飯事のことなのであろうか。答えはNoである。
つまり、データインテグリティにおいて重要なことは、故意か事故かにかかわらずデータのあらゆる意図しない変更から保護することである。

誤解その2 電子記録
データインテグリティにおいて、電子記録に焦点を当てているケースがほとんどである。
では、再び質問である。紙の記録の改ざんと電子の記録の改ざんでは、どちらが患者の安全性にとって重要であろうか。
まったく同じである
データインテグリティの原則は、紙の記録および電子の記録の両者に等しく適用されなければならない。

誤解その3 改ざんの定義
改ざんという言葉を聞くと、不正を想像するのではないだろうか。
それは違う。改ざんとは「意図しない変更」のことを言う。
悪意があろうがなかろうが、意図した変更でないものはすべて改ざんである。
つまり、事故やケアレスミスによって書き換わったデータはすべて改ざんである

誤解その4 意図した変更
意図した変更という言葉も、悪意(不正)を想像するのではないだろうか。
そうではない。例えば、SOPを誤解してデータを作成したり、変更する行為も意図した変更である。
つまり日常的な間違った行為である。作業者は正しいと思って作業しているのではあるが、教育が不十分であったり、長年同じ作業を実施する中で、思い込み、思い入れ、勘違いが生じるのである。
そのため、ダブルチェックや再教育が重要となるのである。

誤解その5 リスクベースドアプローチ
リスクベースドアプローチは、リスクの高い製品やプロセスに焦点を当てると思っている人も少なくない。
そうではない。
規制当局は、患者の安全性を担保するために規制要件を強化する。しかしながら、規制要件を強化すれば企業はコンプライアンスコストを支出しなければならない。増加したコンプライアンスコストは企業が自腹を切るわけではなく、薬価に反映されてしまう。
そのため、患者負担が増大してしまうのである。大げさなことを言えば、高額所得者しか救われない医療になってしまうのである。
このことは規制当局にとってジレンマである。
そこでFDAは2003年9月に、リスクベースドアプローチという新しい医薬品監視プログラムを発表した。
それ以前はGMPによって、どんな医薬品であろうが同じ製造管理、品質管理が求められてきた。
リスクベースドアプローチでは、抗がん剤、向精神薬、ワクチン、血液製剤のようなリスクの高い製品やそれらプロセスはこれまで通り、厳重な製造管理・品質管理を求める。
一方で、ビタミン剤や栄養剤などに代表される比較的リスクの低い医薬品には、それほど厳格な管理を求めないのである。
つまり、リスクにふさわしい程度でコンプライアンスコストを下げ、患者の安全性を担保しつつも患者負担を減らすのがリスクベースドアプローチの概念である。

データインテグリティに関する規程・手順書

イーコンプレスでは「データインテグリティ規程・手順書」のひな形の販売を開始いたしました。

データインテグリティ規程・手順書  55,000円(税込)
【目次】
データインテグリティ規程
1. 目的
2. 適用範囲
3. 用語の定義
4. 背景
5. データインテグリティの原則
6. データガバナンス
6.1 データインテグリティのためのステップ
6.1.1 教育およびコミュニケーション
6.1.2 リスクの発見および低減
6.1.3 技術およびITシステム
6.1.4 データガバナンス
7. 手順書等
8. 参考
9. 付則

データインテグリティ手順書
1. 目的 
2. 適用範囲 
3. 用語の定義 
4. 役割と責任 
5. 啓発活動 
6. 教育訓練 
7. 関連する手順書の改訂 
 7.1 リスクマネジメント 
   7.1.1 リスクの検討 
   7.1.2 リスク低減策の検討 
   7.1.3 リスク低減策の実施 
 7.2 データライフサイクル 
   7.2.1 データの作成 
   7.2.2 データの処理 
   7.2.3 データのレビュ・報告・使用 
   7.2.4 データの保管・維持 
8. コンピュータシステムの見直し、導入 
9. 監視・測定 
10. 監視・測定 
11. 記録の保管 
12. 参考 
13. 付則 

ご購入は こちら

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お好きな時間に、繰り返し何度でもご視聴いただけます。
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データインテグリティ規程・手順書

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