Cognitive debriefing
A process that tests whether translated patient materials are understood as intended.
What it means
Cognitive debriefing is a qualitative research step in which patients or subjects from the target population read and explain translated materials back to the researcher. It confirms that the translated content is understood as intended, especially for patient-reported outcomes, informed consent forms, and questionnaires.
Why it matters for LATAM submissions
Translated patient materials that are technically correct but culturally or linguistically unclear can fail ethics committee review or produce unreliable data. Cognitive debriefing closes that gap.
Relevant regulators
Related terms
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