CITI Training Practice Exam

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What should investigators reference when unsure if an IND is required for a study?

IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer OR seek opinion from FDA
Consult a clinical trial handbook
Consult the healthcare institution's policy
Contact a pharmaceutical consultant

The correct answer is: IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer OR seek opinion from FDA

When determining if an IND is required for a study, the investigator should reference IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer. This means that if the drug or biological product being used in the study is already approved by the FDA for treating cancer, an IND may not be necessary. B, C, and D are incorrect as they do not provide specific information about IND exemptions and may not be reliable sources in determining if an IND is required. Additionally, seeking opinion from the FDA is the best course of action as they are the regulating authority for IND and can provide the most accurate information.