Drug and Supplements Form
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Revised Policy Date
Summary
If this human subjects study involves the use of any drugs, biologics, supplements, or cosmetics, the study may be subject to the Food and Drug Administration (FDA) regulations.
Helpful Tips
Make sure any appropriate documentation from the FDA is included with the Drug and Supplement Form.
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About the Drug and Supplements Form
If this human subjects study involves the use of any drugs, biologics, supplements, or cosmetics, the study may be subject to the Food and Drug Administration (FDA) regulations. Researchers planning to use these agents in human subjects research must complete this form and include it with their protocol submission. OPRS and the IRB will determine if FDA regulations are applicable to the study.
Learn more:
- https://oprs.research.illinois.edu/forms-templates/forms/drug-supplements-form
- https://oprs.research.illinois.edu/forms-templates/guidance/guidance-ind-exemption-criteria
When to Use This Form
If you answered yes to 12.1.8 (Studying the safety, effectiveness, or outcomes of a drug, dietary supplement, biologic product, or cosmetic) in the New Study Application, you need to complete this form.
If you will be creating or sending data and/or samples to a repository or database to be saved for future research uses for this study, and if you did not yet select yes in Section 12.1.8 of the New Study Application, please update the appropriate New Study Application section and then complete this form.
Additional Information
Replaces the former: "Drug and Chemical Usage Form"
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."
Type of Document
- Forms