临床研究文件 TMF

　　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。¹⁾

　　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.