A case report form (CRF) is a tool the study team uses to record information specified in the protocol and report it from investigators to the sponsor. It may be paper or electronic. Whether a CRF entry is also an original source record depends on where and how that information was first captured; the study team identifies the applicable recording arrangements.
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.
CRF content appears in paper clinical trial forms, eCRF screens, completion guidelines, and data management documents. Translators localize field labels, visit names, adverse event terms, and site instructions, often with restricted character widths and coded terminology, requiring consistency with the study protocol, database standards, and final source data edit-check specifications.
A frequent mistake is translating CRF field labels or response options loosely, such as turning “clinically significant” into “important” or “normal” into “negative,” which can alter the meaning of collected data. Inconsistent translations across sites may cause database discrepancies, query generation, or make safety data difficult to interpret by data managers and reviewers.
From reading to a project
Review status: questions to confirm
Ask the study team where the original information is recorded and how it relates to the CRF. Do not assume every entry is transcribed, or that every CRF field is the original medical record.
Carry the source label, allowed response options and any supplied field codes together; flag ambiguous options for the study team.
Record the cited protocol revision and section. Do not infer a visit schedule or add a field absent from the supplied source.
List actual form/eCRF IDs and revisions, protocol references, fields/options requiring Chinese, approved terms, review owner and return-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 CRF 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.