临床试验听听看 ▎ICH-GCP 4.7

4. INVESTIGATOR 研究者

4.7 Randomization Procedures and Unblinding
随机程序和揭盲

The investigator should follow the trial's randomization procedures, if any, and should ensure that the code is broken only in accordance with the protocol. If the trial is blinded, the investigator should promptly document and explain to the sponsor any premature unblinding (e.g., accidental unblinding, unblinding due to a serious adverse event) of the investigational product(s).

研究者应当遵循试验的随机化程序(如果有)，并应保证依照方案打开随机号码。如果试验采用盲法，研究者应当立即记录并向申办者解释试验用药品的任何提前破盲(如意外破盲，因严重不良事件破盲)。

主要“言”究者简介：

临床试验听听看 ▎ICH GCP 2-3部分目录

临床试验听听看 ▎ICH-GCP 4.1

临床试验听听看 ▎ICH-GCP 4.2

临床试验听听看 ▎ICH-GCP 4.3

临床试验听听看 ▎ICH-GCP 4.4

临床试验听听看 ▎ICH-GCP 4.5

临床试验听听看 ▎ICH-GCP 4.61-4.63

临床试验听听看 ▎ICH-GCP 4.64-4.66

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