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临床试验中的研究者手册用英语怎么说 |
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校对客户提供的译稿时,发现临床试验中的研究者手册被翻译为了Researcher's Manual,这样翻译是按字面意思在翻译,但行业中的专业表达为 Investigator’s Brochure (IB)
ICH GCP 对IB的定义如下:
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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