What Is The AE/SAE Definition And Reporting Requirements In China?

Adverse events: unfavourable medical events that occur during clinical trials, regardless of whether they are related to experimental medical devices.
Serious adverse events： deaths or serious deterioration of health that occur during clinical trials, including fatal diseases or injuries, permanent defects of body structure or body function, need for hospitalization or prolonged hospitalization, and need for medical treatment or surgery Intervention to avoid permanent defects in body structure or body function; events such as fatal distress, fatal death, or congenital abnormalities or congenital disabilities.
In China, CTCAE (Common Terminology Criteria for Adverse Events) is usually used for judging AE severity as Grade 1, Grade 2, Grade 3, Grade 4, and Grade 5. All AEs should be recorded in the Original Medical Record and CRF in a timely and accurate manner. SAE should be reported to the GCP office of the clinical study site, IRB, local NMPA, and local Health Commission within 24 hours.
Takeaway: SAE report is of a stringent timeframe, which should be done in 24 hours.