9.7 report and record: ①serious adverse events: clinical safety management must be informed by fax or scaning within 24 hours, regardless of whether the event is related to the tested product. When it's the first time to report, or each time when SAE needs modification, researchers need to complete serious adverse events spreadsheet in the eCRF, The spreadsheet will be automaticly sent to clinical safety manager xt211311@aliyun.com in the form of email. All serious adverse events are also required in the eCRF spreadsheet severity column to choose "serious". ②Not serious adverse events: all not serious adverse events must be recorded on the eCRF's adverse events page.