Investigator responsibilities under 21 CFR 312 sit in subpart D, sections 312.60 to 312.70: conduct the study to the 1572 and the protocol, control the drug, keep the records and keep them long enough, report to the sponsor, make sure an IRB reviews the work, and open the files to FDA. FDA now plans to rewrite that subpart. Its 2026 Unified Agenda lists a proposed rule, RIN 0910-AJ13, expected in December 2026, "with a focus on clinical trial quality." Nothing in it is law yet. The sensible move for a site is to make sure the record behind each current duty is complete, because that is what any rewrite will be measured against.
In short
- FDA's proposal to revise subpart D is listed for December 2026, the first time RIN 0910-AJ13 has appeared in the Unified Agenda (OIRA, 2026).
- The current rules require investigator records to be kept 2 years after approval or after the study is discontinued and FDA notified (21 CFR 312.62).
- FDA said on September 2, 2026 that it is adding resources for foreign inspections and wants trials that enroll American patients (FDA Voices, 2026).
- 2,182 recruiting studies list a Michigan location, 393 of them Phase 1 (ClinicalTrials.gov, October 4, 2026).
What FDA has said about the rewrite
The Unified Agenda entry is short. FDA "is proposing to revise the responsibilities of sponsors and investigators for the conduct of clinical investigations of human drug and biological products in 21 CFR Part 312 subpart D." The rule "would update the Agency's requirements for sponsors and investigators to reflect the modern clinical trial ecosystem with a focus on clinical trial quality."
It gives two more aims. The rewrite "would improve FDA's ability to ensure the rights, safety, and welfare of trial participants and the reliability of results." And it "would align FDA's requirements with those of our global regulatory counterparts, helping to ensure that sponsors are not incentivized to conduct clinical trials outside of the United States and that studies of drugs and biological products submitted for FDA review are representative of the U.S. population."
The entry also cites 21 CFR parts 54, 312, 314 and 601. Part 54 is financial disclosure by clinical investigators, so that form may be touched too. That is a reading of the citation list, not something FDA has said.
Advarra's review of the agenda, published September 28, 2026, notes that "Little additional information is currently available regarding the proposed rule." Treat any detailed prediction you read with care. What can be said is the direction: quality, participant protection, and the global standard most sites already train to, ICH E6(R3), which our Annex 2 guide covers.
Why a Michigan site should care
FDA's leadership wrote on September 2, 2026 that "Trials that fail to enroll American patients can be less easily generalized to the population the products are intended to treat," and that "The FDA is adding resources for foreign Bioresearch Monitoring (BIMO) inspections to expand oversight at foreign clinical trial sites." Read with the AJ13 abstract, the policy points one way: more of the work, including early-phase work, kept in the United States and inspected.
Michigan has the volume to benefit. A query of the ClinicalTrials.gov API on October 4, 2026 returned 2,182 recruiting studies that list a Michigan location, 1,893 of them interventional and 393 of them Phase 1. Those are studies whose investigators already carry the subpart D duties today.
The current duties, and the record behind each
| Section | What it requires | The record a site keeps |
|---|---|---|
| 312.60 | Conduct per the 1572, the plan and the rules; protect subjects; control the drug; obtain consent | Signed 1572, current protocol, consent forms |
| 312.61 | Give the drug only to subjects under the investigator's or a subinvestigator's supervision | Delegation log, dispensing record |
| 312.62 | Drug disposition records, case histories, retention | Accountability log, source and case report forms |
| 312.64 | Progress, safety and final reports to the sponsor; financial disclosure | SAE reports with dates, final report, financial disclosure and its updates |
| 312.66 | IRB review; report changes and unanticipated problems | IRB approvals, correspondence, deviation log |
| 312.68 | Let FDA inspect and copy records | Files that can be produced on request |
| 312.69 | Locked, limited-access storage for controlled substances | Storage location and access list |
Section 312.62(b) is the one most often underestimated. Case histories "include the case report forms and supporting data including, for example, signed and dated consent forms and medical records," and "The case history for each individual shall document that informed consent was obtained prior to participation in the study." Section 312.62(c) then sets retention: "2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated," or, if none is filed or approved, "until 2 years after the investigation is discontinued and FDA is notified."
How to get ready before the proposal lands
- Audit each open study against the table. For each section, find the record. A missing signature or an undated consent is a problem under today's rule, whatever December brings.
- Write down your retention end dates. Retention runs from an approval or a notice that the site does not control. Ask each sponsor how it will tell you, and record the answer in the study file.
- Check that the 1572 matches the people doing the work. The 1572 is the investigator's signed commitment. A subinvestigator who left, or a new one who never appeared on it, is the commonest gap between paper and practice.
- Confirm controlled substance storage. Section 312.69 asks for "a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited." Keep the list of who has the key.
- Read the proposal when it publishes, and comment. A December 2026 NPRM will have a comment period. A Michigan site that runs both investigator-initiated and industry studies sees costs that FDA needs to hear about.
The mistake most sites make at step 1
They audit the binder and stop. Subpart D duties live in more than one place: the pharmacy's dispensing record, the electronic data capture system, the chart. FDA's inspectors compare them. A clean regulatory binder next to a dispensing log that does not match the case report forms is the finding, and our guide to FDA inspection of a clinical trial site shows how often accountability and records come up.
The single IRB rule, also listed for December 2026, changes the 312.66 side of this; our single IRB guide sets out what a site prepares. For the rest of what we build for research sites, see clinical research.
Where we fit
Our regulatory document tracking follows every expiring item across studies and staff, including 1572s, financial disclosures, delegation logs, licences and training, flags what is missing per study and per person, and assembles the packet when someone is added. It tracks; it does not decide what the regulation requires.
The rewrite will come with its own text and its own comment period. The record you keep today is what it will be read against.
