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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.
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?