SAE reporting and AE reporting
CRF
EVENT, CRF
AE collection will begin after the patient signs the ICF. All AEs must be recorded in the appropriate section of the CRF whether or not the AE is related to the test drug. All AEs should be described in concise medical terms, including at least the following contents:① name;② start time.③ seriousness;④ measures taken;⑤ progress;⑥ association with the test drug.In the event of SEAs during the study period, the investigator should report to the State Food and Drug Administration; the health administrative department; the drug administration department of the relevant province, autonomous region, or municipality directly under the Central Government; the ethics committee of the investigator's research center; and the sponsor to study the SAEs within 24 h. The sponsor is responsible for safety inspections throughout the implementation process and ensuring that the research center completes all SAE reports as required by regulatory agencies and local regulations. At the same time, the sponsor must report to the corresponding regulatory agency in accordance with the requirements of regulatory agencies and local laws.