1. Uncover the blindness according to the normal procedure. If there is no pregnancy or other emergency during the postgraduate period, then the blindness will be revealed according to the normal procedure.
At the end of the experiment, after checking CRF and signature, I-level unblinding was performed. The grouping of subjects was determined by class I blind method for statistical analysis.
After statistics, after statistical judgment, perform 2-level deblurring. Two-stage blind uncovering method was used to determine the new drug group and the control group, and to evaluate the curative effect of the drugs.
2. After the occurrence of 2.SAE, it is generally not necessary to consider whether it is necessary to expose the blindness urgently, but only when the research drugs used have an impact on the choice of treatment methods.
3. Emergency blindness breaking procedure
1, notify the applicant before blindness is broken.
2. According to the information of drugs taken by the subjects provided by express mail, the blind method was broken.
3. The researchers completed the form of blind diagnosis and marked it on CRF.
4. If the applicant cannot be contacted before the blind break, it shall be notified in time after the blind break.