IND / IDE Frequently Asked Questions

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Who is considered the sponsor of an IND or IDE study?

Although widely used in connection with the funding of research projects, the term “sponsor” conveys a different meaning in the context of FDA-regulated research. The sponsor is the individual at CHOP who initiates the IND or IDE, and is responsible for both the oversight of the clinical trial (or single subject IND or IDE) and all communications with the FDA. The sponsor is not the CHOP Pharmacy, or CHOP or the investigational product manufacturer.

Who is the IND manager?

The person to whom responsibility to manage the IND has been delegated. This person submits regulatory documents to the FDA, along with complete copies of the documents to the IND/IDE Support Office. Please review the IND and IDE Sponsorship and Responsibilities Policy for more information.

How do I know whether an IND or IDE is required for a study?

The IND/ IDE Support Office provides comprehensive information to help determine whether or not an IND or IDE is needed for a proposed study.

How do I know whether a Treatment / Single Subject IND is needed?

A Treatment IND / sIND allows an experimental drug to be used to treat a patient while clinical testing and FDA review are still taking place. It is only approved for serious or life-threatening conditions. The IND/IDE Support Office provides guidance to help investigators determine when a Treatment IND / sIND is needed. For more information, please review the Treatment IND / sIND page.