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臨床試驗中的研究者手冊用英語怎么說 |
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校對客戶提供的譯稿時,發現臨床試驗中的研究者手冊被翻譯為了Researcher's Manual,這樣翻譯是按字面意思在翻譯,但行業中的專業表達為 Investigator’s Brochure (IB)
ICH GCP 對IB的定義如下:
The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration and safety monitoring procedures.
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