21 CFR 312.60: Investigator Responsibilities

21 CFR 312.60 (General Responsibilities of Investigators)

21 CFR 312.60 is the FDA regulation establishing that an investigator conducting an IND-regulated clinical investigation is responsible for: conducting the study according to the signed investigator statement (Form FDA-1572) and the investigational plan/protocol; protecting the rights, safety, and welfare of subjects under the investigator's care; and controlling drugs under investigation, including obtaining informed consent under 21 CFR Part 50 and complying with IRB requirements under 21 CFR Part 56.

ByCASRAI Editorial Board

· Last updated 3 Aug 2026

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Examples

Worked examples

Is an instance
A subject undergoes a study procedure before signing an IRB-approved informed consent form -- an FDA inspector can cite this as a 312.60 finding (failure to protect subject rights/welfare) independent of the separate Part 50 consent requirement.
Is an instance
A PI signs Form FDA-1572 committing to conduct the trial per protocol; 312.60 is the regulation that makes living up to that signed commitment a binding legal responsibility, not just a paperwork formality.

Counter-examples

Looks similar, but isn't

Not an instance
A single missed daily drug-accountability log entry by a study coordinator is, on its own, a 312.62 recordkeeping matter -- it only becomes a 312.60 concern if it reflects a broader breakdown in the investigator's control over the drug supply.

Machine-readable encodings

Use in your systems

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Schema.org DefinedTerm (JSON-LD)

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