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• NIH investigators and non-NIH investigators conducting human subjects research involving drugs, biological products, medical devices, or nutritional products, must comply with all applicable FDA regulations.
• An investigator is responsible for ensuring that an investigation is conducted according to the signed Investigator Statement (Form 1572^{Image Removed}), the investigational plan, and applicable regulations.
• Sponsors for FDA regulated research have additional responsibilities such as reporting and monitoring requirements.

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