Clinical CRF Translation Services

A paper CRF is typically presented as a formatted physical or printable form, while an electronic CRF presents study data-entry content within an electronic data capture environment. Both require accurate clinical language and terminology consistency. eCRF translation can introduce additional requirements involving structured strings, field identifiers, UI constraints, implementation files, text expansion, and in-context linguistic QA.

The localization scope depends on the study and EDC configuration. User-facing elements such as form names, field labels, questions, response display text, instructions, and help content may require translation. Technical elements such as variable names, field IDs, internal codes, programming logic, mappings, and database identifiers may need to remain unchanged. Sesen establishes project-specific translation rules so each content type is handled appropriately.

Often, no. These elements may form part of the controlled technical structure of the study or EDC system. They should generally remain unchanged unless the sponsor, data-management team, or technology provider specifically designates them for localization. Sesen can protect nontranslatable technical elements while translating the corresponding user-facing content.

Yes. Sesen can support structured eCRF content supplied through spreadsheets, string tables, system exports, localization packages, and other agreed exchange formats. The workflow can preserve identifiers and field relationships needed by the sponsor, CRO, clinical data management team, or eClinical provider for subsequent implementation.

Where a sponsor uses CDISC/CDASH conventions or another structured clinical data model, Sesen can align the localization workflow with the study's provided terminology, naming conventions, controlled elements, and localizable display content. Sesen's role is to preserve the intended language within the established study structure rather than redefine the underlying clinical data standard.

Sesen can use the protocol, amendments, CRF specifications, sponsor glossaries, translation memories, existing translations, and related study references to establish terminology before and during translation. Approved terminology can then be maintained across forms, fields, languages, and subsequent study versions.

When a CRF changes, Sesen can compare the revised source against previously translated versions, identify new and modified content, reuse approved translations where the source remains unchanged, and translate the required delta. Terminology resources and translation memories help maintain consistency across amendment cycles.

Not automatically. The appropriate translation methodology depends on the sponsor's requirements, SOPs, intended use, content type, and study workflow. Many operational CRFs can be managed through professional translation, independent review, contextual QA, and final quality control. Back translation and reconciliation can be added when specifically required.

CRFs and eCRFs are structured tools used to collect clinical study data. eCOA and ePRO systems contain clinical outcome assessment instruments designed to measure patient, clinician, observer, or performance outcomes. COA instruments may require formal linguistic-validation methodologies designed to demonstrate conceptual equivalence across languages and cultures. These requirements are not automatically applicable to every CRF.

Yes, when suitable contextual materials or system access are available. Sesen can perform in-context linguistic QA using screenshots, review environments, exports, or other agreed materials to identify translation, truncation, terminology, placement, and display issues that may only become visible after implementation.

Yes. Sesen supports clinical translation in more than 150 languages. Centralized project management, terminology governance, translation memories, structured QA, and version control help multinational study teams maintain consistency as CRFs are deployed across countries and updated during the study.

Yes. Sesen can translate user-facing CRF fields used to collect adverse events, serious adverse events, concomitant medications, medical history, and related safety information. Broader pharmacovigilance requirements—such as individual safety cases, safety narratives, aggregate reports, signal and risk content, and post-market safety communication—are supported through Sesen's dedicated pharmacovigilance workflow.