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Social Studies, 15.04.2020 21:13 rebekah052482

An investigator proposes to study a marketed product sold to treat high blood pressure in individuals over age 12 using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in younger children. Which of the following is the investigator's most appropriate course of action?

Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research
Discard the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research
All of the above
none of the above

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