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Can a copy of icd be given to subject at discretion of the investigator in a clinical trial?
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∙ 10y ago
No, the investigator should not give a copy of the Investigator's Brochure (formerly known as the Investigator's Clinical Dossier) to trial participants. The Investigator's Brochure is intended for the investigator's reference to ensure they have a comprehensive understanding of the investigational product being studied. Providing this document to participants could pose potential risks such as confusing or misleading information. Participants should instead be provided with an informed consent form that includes relevant details about the trial.
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