Serious Adverse Event严重不良事件
A serious adverse event is an untoward medical occurrence during a clinical trial or after product exposure that results in death, is life-threatening, requires inpatient hospitalization or prolongation, causes persistent or significant disability/incapacity, or leads to a congenital anomaly. In safety reporting and clinical study reports, SAEs are classified, assessed for causality, and reported to regulators within defined timelines.
Updated
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
In translation and localization, SAE narratives, safety case forms, and expedited reporting templates appear across clinical safety documents. Translators often process investigator-facing case report forms, patient adverse-event narratives, and pharmacovigilance reports for submission in multiple countries. Consistent rendering of MedDRA terms and severity scales is important for regulatory review.
Translation checks
A common error is translating “serious” as “severe” in languages where the terms can overlap; in regulatory English these are not equivalent, because seriousness is a regulatory reporting criterion while severity describes intensity. Under-translating the SAE criteria can cause misclassification, delayed reporting, and rejection of safety submissions.
Chinese document application
Serious Adverse Event in context · safety reporting form
- English source
- Refer the serious adverse event for the specified review.
- Chinese rendering to review
- 将该严重不良事件提交规定的审核。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
Serious and severe are not interchangeable classifications in clinical documentation. Preserve the exact source category and the stated review route without adding reporting deadlines or legal conclusions. Keep the event identifier connected to the corresponding record.
Check the returned Chinese file
Check the Chinese classification label against the source procedure’s definitions. Keep the event identifier and reporting-route reference together, and return any conflict between seriousness and severity wording for the medical owner’s decision.
Prepare the connected files
Provide the safety terminology and source procedure references. The responsible medical or regulatory owner should confirm classification and reporting requirements separately.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishVaccine-production process documentation, SOPs, quality-control standards and microbiology-testing procedures.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.