改ざんとは
昨今、当局における改ざんの問題が世間をにぎわしている。
しかしながら「改ざん」の定義について正確に理解されていないケースが多い。
「改ざん」は悪意のある不正行為であると理解している人が多いようである。
実はそうではない。
「改ざん」は、文書、記録等の全部又は一部が、本来なされるべきでない時期に、本来なされるべきでない形式や内容などに変更されること、すること、をいう。故意の場合も過失の場合もともに含み、悪意の有無を問わない。
「改ざん」という概念は、悪意が無い場合も含んでおり、たとえばその変更が不適切であるか否かが厳密に定義できる分野では、悪意がなくても誤解や知識不足によって不適切な変更を行った場合や、パソコンの誤操作等の事故による意図的でない変更は「改ざん」にあたる。
データインテグリティと改ざんについて
データインテグリティの目的の一つとして、データが改ざんされていないことを保証することがあげられる。
患者の安全性にとって、故意によるデータの改ざんも入力ミスや転記ミスといった事故による改ざんも等しく問題となる。
多くのデータインテグリティに関するセミナーや書籍においては、悪意のある不正な改ざんに焦点が当たり過ぎている感がある。
しかしながら、不正による改ざんがそんなに多い訳ではない。
製薬企業として確立し対応しなければならないのは、不正よりも悪意のない改ざんである。
悪意のない改ざんには、故意による改ざんと非故意による改ざんに分類される。
前者は、手順書を理解していなかったり、思い込みにより悪意はないもののわざとデータを変更してしまう事案である。本人が気づくことなく日常的な違反を繰り返してしまう。
後者は不注意によるデータ入力ミスや転記ミスなどがあげられる。
一般に故意による改ざんは全体の20%を占め、非故意による改ざんは全体の80%を占めるといったデータもある。
医薬品の有効性と安全性を担保するためには、不正による改ざんよりも、悪意のない改ざんを防ぐ必要があり、知らず知らずに起こしてしまう非故意による改ざんを防止することが喫緊の課題であると言える。
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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