When a serious adverse event happens, investigators must fill out the “SAE form” and report it to the major investigator and center ethics committee immediately. The event should be reported to the safety supervision division of the State Food and Drug Administration within 24 h.
The major investigator must offer corresponding treatment according to the drugs and symptoms, then record and sign at the CRFs in detail. The inspector must be informed of the treating processes.
All adverse events should be recorded in time and tracked until properly resolved or stabilized. Abnormal indexes in physical and chemical examinations should be checked until normal.
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