電子署名が必要な電子文書

FDAによるPart11では、電子署名が必要な文書は「法的拘束力のある署名」に限っています。
従って、対応となる文書や記録はさほど多くはありません。
つまりFDAに電子的に提出するか、提出した資料の根拠となった電子的な資料が対象となります。
FDAに提出した資料をN次データとすると、N-1次データまでがその対象となるわけです。
勘違いしてはならないのは、電子承認がすべて電子署名と同等ではないということです。
電子承認と電子署名を混同してはいけません。
一方、厚生労働省令第44号では、電子文書の作成にあたって、その氏名を明らかにする措置を講じなければならない場合は、電子署名を用いることとなっています。
例えばEDCシステムにおいて、CRFを電子的に作成する(つまりペーパレス化する場合)、治験責任医師は電子署名を用いなければなりません。
まだまだ電子署名は時期早尚であるため、CRFを紙に印刷して記名・捺印を受けるという方法が主流となるでしょう。
FDAはCRFの電子化について、電子署名を義務付けていません。
ただし作成にあたっては、ユーザIDとパスワードの管理を徹底してを行い、作成後の監査証跡も厳重に記録・保存しなければなりません。
つまりセキュリティとオーディットトレールは必須です。

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