A case report form (CRF) is the structured document—paper or electronic—used to collect each clinical trial subject’s data according to the approved protocol and final study schedule. It contains coded data fields for eligibility, planned assessments, dosing, adverse events, safety information, and outcomes, and serves as the source for clinical database entry, statistical analysis, and sponsor regulatory review.
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.
FDA, CE/MDR and NMPA reviewers assess the submitted wording itself. Regulatory bodies require traceable, accountable translation, and an inconsistent term can delay or fail a submission.
Angel Translation locks terms like this into a project terminology base before expert review begins, so the same source term resolves to the same target term across every document in a submission — and stays consistent in the next revision. See the 8-step AI + expert workflow.
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