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Overview of Responsibilities of Investigators

An investigator who conducts a clinical investigation of a drug, biologic, or device is required by the FDA to

  • Ensure that the clinical investigation is conducted according to the signed investigator statement for clinical investigations of drugs, including biological products (Form 1571 for sponsor responsibilities and Form 1572 or equivalent for investigator responsibilities) or agreement for clinical investigations of medical devices, the investigational plan (protocol and other supporting documentation), and applicable regulations
  • Protect the rights, safety, and welfare of subjects under the investigator's care
  • Control the drugs, biological products, and devices under investigation.

These responsibilities are detailed in 21 CFR 312 (drugs and biological products) and 21 CFR 812 (medical devices).

Additionally, the investigator commits to personally conduct or supervise all aspects of the investigation. The investigator is legally responsible for all aspects of the investigation and cannot delegate this responsibility to another individual.

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