Adverse Event不良事件
An adverse event is any undesirable medical occurrence experienced by a patient or clinical trial subject during treatment, regardless of whether a causal relationship with the product has been established. In clinical and post-market safety documentation, adverse events appear in case report forms, safety narratives, and periodic reports, where accurate translation is critical for causality assessment, regulatory submission, and signal detection.
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
Adverse event terminology appears in clinical trial documents, safety databases, pharmacovigilance reports, and post-market surveillance files. Translators must accurately translate event descriptions, medical history, and outcomes, often under tight timelines, because coded terms and narratives feed directly into regulatory submissions, signal detection activities, and data monitoring committee reviews.
Translation checks
A frequent mistake is confusing 'adverse event' with 'adverse reaction' or assuming causality when the source text does not state it. This can alter the safety record, affect incidence data, or create false attribution in translated narratives, which may mislead safety reviewers and regulators during assessment and case processing.
Chinese document application
Adverse Event in context · event-reporting text
- English source
- Record the adverse event in the designated form.
- Chinese rendering to review
- 在指定表格中记录不良事件。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
An adverse event and an adverse reaction are not automatically the same concept. Keep the source wording about causality, timing and status intact. A translator should not infer a causal relationship or select a classification absent from the source.
Check the returned Chinese file
Compare the Chinese event description with the causality and outcome fields. Each field should preserve the source distinction, and no prefilled translated option should imply that a medical classification has already been selected.
Prepare the connected files
Supply approved event terminology and the relevant blank form. Ask the medical owner to resolve any inconsistent event classification in the source.
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
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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.