A clinical study report (CSR) brings the design, conduct and findings of an individual human clinical study into a report with the corresponding statistical material. It links the report narrative, tables, figures and supporting appendices. ICH E3 describes a core structure; the study, intended use and applicable submission arrangements determine the actual report set.
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.
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.
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.
From reading to a project
Review status: questions to confirm
Check section numbers, table/figure identifiers and appendix references against the supplied report version.
Preserve source-defined analysis-set names, endpoint labels and table notes; route unclear source wording to the responsible study contact.
List protocol, CRF samples or statistical appendices only when they are included in the project inventory; do not imply they are present by default.
List report version, included sections/appendices, table and figure references, terminology, review owner and requested Chinese file format.
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.
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 a Chinese CSR file inquiry →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.