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Microbiology and Infectious Diseases Clinical Research Policies, Guidance, and Tools

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Investigational Product

An investigational product refers to a preventative (vaccine), a therapeutic (drug or biologic), device, diagnostic or palliative used in a clinical trial. An investigational product may be an unlicensed product or a licensed product when used or assembled (formulated or packaged) differently from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.

The following links provide DMID staff and DMID clinical investigators with information on DMID procedures for handling and administering investigational products in DMID-funded clinical trials. The DMID Office for Regulatory Affairs (ORA) should be contacted for specific questions.

DMID supports a clinical agent repository for procuring and shipping investigational products used in DMID sponsored research.

DMID Guidances and Tools

Additional Information

  • Selected References page under
    • Food and Drug Administration for IND and IDE regulations
    • International Conference on Harmonisation- E-6 ( accountability-4.6; product supply and handling-5.14 and IB-7.0)

    Last Updated March 14, 2013