21 CFR 812.100
§ 812.100 General responsibilities of investigators.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 812.100, § 812.100 General responsibilities of investigators, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88840
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Full 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.