Main Content

Drug and Chemical Usage Form

You are here

Drug and Chemical Usage Form

If this human subjects study involves the use of any drugs or chemical or biological agents, the study is subject to Food and Drug Administration (FDA) regulations. Researchers planning to use these agents in human subjects research must complete this form and include it with an original New Protocol Application or a Protocol Amendment Form, as applicable.

Note: For drugs or biologics that are investigational, the consent document must clearly indicate that the agent is "investigational (experimental)" and that "an investigational drug is one that is not approved by the Food and Drug Administration (FDA) for the use being studied."