没有专门关于盲态监查的指南。FDA “The establishment and operation of clinical trial data monitoring committees for clinical trial sponsors” 3.4. Site/Clinical Monitoring里提到 ...In blinded studies, these monitors remain blinded to study arm assignment. ICH GCP 5.18.3 The determination of the extent and nature of monitoring should be based on considerations such as the objectives, purpose, design, complexity, blinding… of the trial.