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In the REVISE project (Reviewing the Supporting Evidence in Investigator’s Brochures), we look into attitudes toward Investigator’s Brochures (IBs), a key document for independent review-procedures in translation. To make a clinical trial ethical, regulatory agencies and institutional review boards have to judge whether the trial-related benefits outweigh the trial-inherent risks. These risk-benefit assessments are based on evidence from preclinical and clinical studies reported in IBs. They present the collected preclinical and clinical evidence relevant to the study of an investigational product(s) in human subjects and aim to inform clinical investigators, regulatory authorities, and institutional review boards (IRBs).
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