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Announcing the MAGI eRegulatory Binder Reference Model Version 0.9

机译：宣布MAGI eRegulatory活页夹参考模型0.9版

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In a previous article, we discussed the MAGI eISF+eTMF Initiative.1 In summary, the major deliverable of a clinical study is an organized collection of documents called a Trial Master File (“TMF”). Electronic TMF (“eTMF”) systems have been widely adopted to streamline the process of collecting study documents and preparing then for submission to the FDA and other regulatory authorities. More recently, research sites have been rapidly adopting electronic regulatory binders (“eReg Binders”), also known as electronic investigative site files “eISFs,” to collect and manage their documents. Many of these documents end up the sponsor’s eTMF, so there should be a way to efficiently transmit these documents, literally at the click of a button.
机译：在上一篇文章中，我们讨论了MAGI eISF + eTMF计划。1总之，临床研究的主要成果是有组织地收集了称为审判主文件（TMA）的文件。电子TMF（“ eTMF”）系统已被广泛采用，以简化收集研究文件并准备提交给FDA和其他监管机构的过程。最近，研究站点已迅速采用电子监管联编程序（“ eReg Binders”），也称为电子调查站点文件“ eISF”，以收集和管理其文档。这些文件中的许多文件都以赞助商的eTMF结尾，因此应该有一种有效地传输这些文件的方法，只需单击一下按钮即可。

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