21CFR812.100

§ 812.100 General responsibilities of investigators.

Regulation Text

An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the investigator's care, and for the control of devices under investigation. An investigator also is responsible for ensuring that informed consent is obtained in accordance with part 50 of this chapter . Additional responsibilities of investigators are described in subpart G.

Authority

21 U.S.C. 331,351,352,353,355,360,360c-360f,360h-360j,360hh-360pp,360rr-360ss,360bbb-8b,371,372,374,379e,381,382;42 U.S.C. 216,241,262.

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Related Guidelines (8)

Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials: Guidance for Sponsors, Clinical Investigators, and IRBs (Status: Final)
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Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects: Guidance for Industry (Status: Final)
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In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
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Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers: Guidance for Institutional Review Boards, Investigators, and Sponsors (Status: Final)
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Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
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Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies (Status: Final)
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Conducting Clinical Trials With Decentralized Elements (Status: Final)
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Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices (Status: Draft)
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