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.
Editorial commentary
21 CFR 312.60 is the FDA regulation, within the Investigational New Drug (IND) framework, establishing the general responsibilities of an investigator conducting an IND-regulated clinical investigation. It is the anchor provision that several more specific investigator-obligation regulations — recordkeeping, sponsor reporting — implement in more detail.
What the regulation requires
Per the regulatory text, an investigator is responsible for: ensuring the investigation is conducted according to the signed investigator statement (Form FDA-1572), the investigational plan, and applicable regulations; protecting the rights, safety, and welfare of subjects under the investigator’s care; and controlling drugs under investigation. The regulation also requires compliance with the informed-consent requirements of 21 CFR Part 50 and the IRB requirements of 21 CFR Part 56.
How it relates to other 21 CFR 312 provisions
312.60 is deliberately the general, anchor responsibility provision. Two related but distinct regulations implement specific pieces of it:
- 21 CFR 312.62 covers investigator recordkeeping and record retention — maintaining adequate records of investigational-drug disposition and case histories.
- 21 CFR 312.64 covers investigator-to-sponsor reporting — progress reports, safety reporting, and final reports.
A single missed daily drug-accountability log entry by a study coordinator is, on its own, typically a 312.62 recordkeeping matter rather than a 312.60 finding — it only rises to a 312.60 concern if it reflects a broader breakdown in the investigator’s control over the drug supply, rather than an isolated clerical lapse.
Where 312.60 sits in investigator accountability
The investigator’s commitment to 312.60’s responsibilities is formalized through Form FDA-1572, the Statement of Investigator, which the principal investigator signs before a sponsor may permit participation in a trial. 312.60 is the regulation that makes living up to that signed commitment a binding legal responsibility rather than a paperwork formality — an FDA inspection finding under 312.60 reflects a failure of the investigator’s underlying obligations, not just an administrative gap. Where a PI delegates specific study tasks to sub-investigators or coordinators, the resulting Delegation of Authority Log (see also the DoA log template guide) documents who is doing what, but 312.60 responsibility for the overall conduct of the trial remains with the investigator regardless of delegation.
Examples
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 and welfare) independent of the separate Part 50 consent requirement it also violates. A PI signs Form FDA-1572 committing to conduct the trial per protocol; 312.60 is the regulation that makes that signed commitment legally enforceable.
Frequently Asked Questions
What does 21 CFR 312.60 require of an investigator?
Conducting the investigation according to the signed investigator statement and investigational plan, protecting subjects’ rights/safety/welfare, and controlling the investigational drug — including compliance with informed-consent (Part 50) and IRB (Part 56) requirements.
How is 312.60 different from 312.62?
312.60 is the general responsibility provision; 312.62 specifically covers recordkeeping and record retention for investigational-drug disposition and subject case histories. A recordkeeping lapse is usually cited under 312.62 unless it reflects a broader failure of overall drug control, which can also implicate 312.60.
Does delegating tasks to a sub-investigator shift 312.60 responsibility away from the PI?
No. Delegation, documented on the Delegation of Authority Log, distributes specific tasks, but the principal investigator retains overall 312.60 responsibility for the trial’s conduct.
References
- 21 CFR 312.60, “General responsibilities of investigators” (eCFR / law.cornell.edu).
- 21 CFR 312.62 (recordkeeping) and 312.64 (investigator-to-sponsor reporting).
Machine-readable encodings
Use in your systems
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