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制定本清单的目的是确保临床试验中数据管理的文件及记录被规范地完整地存档,它适用于包括Ⅰ期至Ⅳ期的所有临床试验。
The purpose of this checklist is to ensure that documents and records of data management in clinical trials are properly and completely archived and are valid for all clinical trials including stage I to stage IV.