The Sponsor of a clinical trial has provided an informed con.pdf

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The document discusses a clinical trial sponsor providing an informed consent template for a new trial, with clinical investigators still responsible for ensuring the template meets ICH-GCP and FDA regulations. It also states that in the United States, Institutional Review Board oversight of participant safety and well-being in clinical trials is required by law.

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The Sponsor of a clinical trial has provided an informed consent template to be used for a new
clinical trial. Clinical investigators still have the responsibility for ensuring that the informed consent
document is adequate and contains the requirements listed in ICH-GCP and the FDA's
regulations. True False Question 7 ( 2 points) Institutional Review Board (IRB) oversight of the
safety and well-being of human participants is required by law in the United States. True False

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