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My PI asked what FDA actually expects of her. Which document do I send?

FDA's guidance, "Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects," explains what FDA expects of clinical investigators. It is available on FDA's guidance documents page.

Open the official source
Official sourceFDAwww.fda.gov
Checked on October 15, 2026

Next steps

  • Read "Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects."

From the question: My PI asked what FDA actually expects of her. Which document do I send?