====== 临床研究文件 TMF ======

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　　**临床研究文件（夹）**是临床试验相关文件的总和，包括研究者文件（ISF）和申办方存档的文件。(([[email@CRANote.com|老T]] 编撰于 2017/09/29 16:54))

　　A **Trial Master File (TMF)** should be set up at the beginning of a trial. The essential documents that make up the file should be kept in a secure but accessible manner.  A well-kept TMF can help with efficient trial management and can facilitate the reconstruction of the conduct of the trial during the audit/inspection process.

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