[Answer] If the FDA determines that an IND is not required in a drug study then which of the following is true?

Answer: The investigator should prepare and submit a protocol and consent document to the IRB. These materials should include the fact that the FDA advised that an IND is not required. - The investigator should prepare and submit the protocol to the IRB as an approval would be necessary. The materials should include the fact that the FDA has advised the investigator that an IND is not required. Informed consent is still a requirement unless the IRB indicates that it may be waived. There is no justification for limiting enrollment to just adults.

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If the FDA determines that an IND is not required in a ...

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