Clinical Study Report临床研究报告
A clinical study report is a comprehensive document that describes the objectives, design, methodology, statistical analysis, efficacy results, and safety findings of a completed clinical trial. It is included in the clinical efficacy and safety module of regulatory submission dossiers and serves as the primary source reviewers use to evaluate the benefit-risk profile of an investigational product and to support labeling claims.
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, clinical study reports are often translated as part of eCTD Module 5 or similar clinical submission packages for marketing applications. Translators handle large data tables, adverse event narratives, statistical output, and figure legends, and must keep terminology aligned with the protocol, statistical analysis plan, and case report forms.
Translation checks
A frequent mistake is translating adverse event narratives with added interpretation or omitting causal language such as “possibly related,” which alters safety assessment. Statistical terms may also drift from those used in the protocol, for example rendering “treatment arm” differently across sections, making efficacy results harder for reviewers to verify.
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 → EnglishQuality manuals, SOPs, production-process and clinical-trial documentation.
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.