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Translating Informed Consent Forms: Accuracy, Readability, and Patient Understanding

An informed consent form serves a purpose beyond documenting a participant’s agreement to join a clinical trial. It provides information people need when deciding whether participation is right for them. When a study involves participants who speak different languages, that information must remain accurate, understandable, and consistent across translations.

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Clinical Trial Translation: A Practical Checklist for Sponsors and CROs

Clinical trial documentation rarely stays unchanged from study startup to closeout. Protocols are amended, patient materials are updated, and country-specific requirements must be addressed as a study progresses. When several languages are involved, each change can affect more than one document, team, or submission.

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