データにおける動的電子記録と静的電子記録について

生データとは

生データの定義はFDAのGLP規則である21 CFR Part 58.3(k)に記載がある。

“生データ”とは、実験室内のワークシート記録書、覚え書き、注意書き、またはその正確なコピーをいい、これは非臨床試験の原観察結果およびその業務についての成績であり、この試験の報告の再構成および評価のために必要である。
生データの正確な転写(例えば、そのまま転写され、日付をつけ、署名によって正確であると確認されたテープ)が用意された場合には、その正確なコピーまたは正確な転写を生データとしてもとの資料と置き換えることができる。生データは写真、 マイクロフィルムまたはマイクロフィッシュ、コンピュータ記録、観集結果を口述した磁気記録および自動装置から記録されたデータでもさしつかえない。”

つまりそれ以前に記録がなく、初めて記録されたものが生データである。
しかしながら、感熱紙などに記録が印刷される場合、そのままでは経年劣化し茶けてしまう。
その場合、正確なコピー(またはスキャン)をとり、コピーをした人の署名、日付を付すことによって生データに置き換えることができる。
このような生データの正確な転写を”True Copy”または”Certified Copy”と呼ぶ。

動的電子記録と静的電子記録

動的電子記録とは例えば動画(ビデオ)である。静的電子記録とは例えば静止画像(写真)や紙コピー である。
静的電子記録(写真や紙コピー)が生データとなる場合は多くある。
しかしながら、生データがビデオ(例:スモッグテストの記録)である場合、その1シーンを切り出した写真は”True Copy”とはならない。したがって生データではない。

クロマトグラムのバイナリーデータ(動的電子記録)は、再解析が可能でベースラインや隠れている領域を拡大してみることができる。
しかしながら、紙媒体に印刷したチャート(静的データ)ではそれらの操作が不可能である。
したがって、規制当局はクロマトグラムのチャートは生データまたは”True Copy”とは認めない。

本邦においては、クロマトグラムのチャート(印刷)を生データとして保存し、バイナリデータを破棄しているケースが多くみられる。しかしながら、FDAやMHRAなどの規制要件では、クロマトグラムのチャート(印刷)は生データとは認めないので注意が 必要である。
バイナリデータは決して削除してはならないのである。

ちなみに、クロマトグラフィに相等するデータベース形式の動的電子記録であれば、データを追跡調査、傾向調査、クエリーすることができ、適切なアクセス権限があれば、レビュワーは再解析し、隠れたフィールドを表示し、ベースラインを引き延 ばし積分をさらに詳細に見ることができる。

動的電子記録の”True” Copyは、オリジナル記録の内容と意味が保存され、適切なリーダーと複写装置(例、メディアリーダーを含むソフトウェアやハードウェア)が容易に入手可能であることが条件で、オリジナル記録の形式あるいは互換性のある形式で作成し維持することが できなければならない(§211.180(d)、§212.110)。

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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