21 CFR 312.60 - General Responsibilities of Investigators

What it says

An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan and applicable regulations, for protecting the rights, safety and welfare of subjects under the investigator's care, and for control of drugs under investigation. An investigator must obtain informed consent and must not make changes to the research without approval, except to eliminate an immediate hazard to subjects.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The investigator signs a statement committing to these duties, so responsibility is personal.
• Delegation to staff is allowed, but the investigator remains responsible for supervision.
• Control of the investigational product means accountability for every unit received, dispensed and returned.

What FDA inspectors look for

• Whether the protocol was followed and deviations documented.
• Whether consent was obtained before study procedures.
• Whether investigational product accountability records are accurate.

Related regulations