Review the following questions and select the best option by answering either "Yes" or "No" as it applies to your new study submission. Your selections on each proceeding page will help identify the most likely level of review.

Will your research involve the study of a drug/biological product or device

• for which an IND¹ or IDE² has been obtained, or will be obtained prior to initiation of the study?
• to support a new indication?
• which will be administered through randomization?
• which will be administered to a subject within a vulnerable population³?

• Select "Yes" (to any of the above)
• Select "No"

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