21 CFR 312.60 (General Responsibilities of Investigators)

21 CFR 312.60 is the FDA regulation, within the Investigational New Drug (IND) framework, titled “General Responsibilities of Investigators.” It sets out the baseline accountability of any clinical investigator conducting a drug study under an IND: conduct the study as committed, protect subjects, and control the investigational drug.

The regulatory text

21 CFR 312.60 states that an investigator is responsible for: (1) ensuring the investigation is conducted according to the signed investigator statement (FDA Form 1572), the investigational plan, and applicable regulations; (2) protecting the rights, safety, and welfare of subjects under the investigator’s care; and (3) the control of drugs under investigation. It also requires the investigator (or a sub-investigator) to obtain informed consent from each subject in accordance with 21 CFR Part 50, and to comply with Institutional Review Board (IRB) requirements under 21 CFR Part 56.

Why it matters

312.60 is the anchor provision for investigator accountability in FDA-regulated drug trials. It doesn’t itemize specific tasks the way the recordkeeping and reporting sections that follow it do — instead, it establishes the general duty that those more specific sections implement. FDA inspectors and sponsors use 312.60 as the baseline standard against which a principal investigator’s (PI) overall conduct of a study is measured, separate from any single documentation lapse.

How 312.60 relates to Form FDA-1572

When a PI signs Form FDA-1572 before a study begins, they are making the specific commitments 312.60 then holds them to: to personally conduct or supervise the investigation, to conduct it according to the protocol, to obtain informed consent, to report adverse events per the applicable reporting requirements, and to ensure all associates and subinvestigators are informed of these obligations. The 1572 is the signed statement; 312.60 is the regulation that makes conduct consistent with that statement a legal obligation, not just a paperwork exercise.

This obligation is not removed by delegation. A PI who delegates specific trial-related tasks to study staff via a Delegation of Authority (DoA) log transfers performance of those tasks, not the underlying 312.60 responsibility for the study’s overall conduct, subject protection, and drug control — the PI remains accountable at the study level regardless of who physically performed a given task.

312.60 vs. 312.62 vs. 312.64

These three adjacent Subpart D sections are often confused because they apply to the same investigator role, but they cover different obligations:

• 312.60 (general responsibilities): the broad duty to conduct the study per the signed statement and protocol, protect subjects, and control the drug supply.
• 312.62 (recordkeeping and record retention): the specific duty to maintain adequate case histories and drug-disposition records, and to retain them for a defined period after marketing approval or study discontinuation.
• 312.64 (investigator reports): the specific duty to report safety information, progress, and study completion to the sponsor on defined schedules, including immediate reporting of serious adverse events.

In practice, a 312.62 or 312.64 finding (a missing log entry, a late safety report) is usually also framed by FDA as evidence bearing on the investigator’s broader 312.60 responsibility, since the specific sections implement the general one.

Worked examples

Example 1 — informed consent gap. If a subject undergoes a study procedure before signing an IRB-approved informed consent form, this is a 312.60 finding: it reflects a failure to protect the rights and welfare of a subject under the investigator’s care, even though the consent process itself is separately governed by 21 CFR Part 50.

Example 2 — protocol deviation pattern. An investigator who repeatedly enrolls subjects outside the protocol’s eligibility criteria is not conducting the investigation “according to the investigational plan,” which is a direct 312.60 responsibility — distinct from any single deviation’s documentation under 312.62.

Counter-example

A study coordinator’s single missed daily drug-accountability log entry is, on its own, a recordkeeping matter under 312.62, not automatically a 312.60 violation. It becomes a 312.60 concern only if it reflects a broader failure of the investigator’s control over the drug supply — the general responsibility 312.60 establishes — rather than an isolated clerical gap.

Frequently asked questions

What does 21 CFR 312.60 actually require?

It requires an investigator conducting an IND study to conduct the investigation per the signed investigator statement and protocol, protect subjects’ rights, safety, and welfare, and control the investigational drug, including obtaining informed consent under Part 50 and complying with IRB requirements under Part 56.

Is 312.60 the same as Form FDA-1572?

No. Form FDA-1572 is the signed pre-study document in which the investigator makes specific commitments (protocol adherence, personal conduct/supervision, IRB compliance, and more). 21 CFR 312.60 is the regulation that makes living up to those commitments a general legal responsibility.

Does delegating tasks reduce an investigator’s 312.60 responsibility?

No. Delegation, documented in a Delegation of Authority log, transfers who performs a task — it does not transfer the investigator’s underlying 312.60 accountability for the study’s conduct, subject protection, and drug control.

How is 312.60 different from 312.62 and 312.64?

312.60 is the general responsibility provision. 312.62 covers the specific duty to keep and retain records (case histories, drug disposition). 312.64 covers the specific duty to submit reports to the sponsor (progress, safety, completion) on defined schedules.