この記事の翻訳を準備しています。それまでの間、英語の原文を表示します。
ビジネス · 2001/11/201 分で読めます
Draft “Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees;” Availability
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees" dated November 2001. The draft guidance document, when finalized, will assist sponsors of clinical trials in determining when a data monitoring committee (DMC) is needed for optimal study monitoring and how such committees should operate.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →