Records, Escalation and Who to Tell
Part of Conflict of Interest in Clinical Research: Managing and Documenting Conflicts.
About 5 minutes. Free, in your language, no account needed.
Expert review pending. CRLN wrote this lesson against the primary sources listed under References. A subject-matter expert has not yet reviewed it. Where your institution's policy or your sponsor's instructions are stricter, follow them.
Why this matters
If it is not documented, an inspector or auditor has to assume it did not happen. Conflict of interest work leaves a paper trail: disclosures, determinations, plans, recusals and updates. This lesson covers what to keep, where it usually goes, and what to do when you think a conflict is being missed or ignored.
What to file, and where
Sites organize records differently, so always follow your institution's and sponsor's filing instructions. A typical set looks like this:
| Record | Usually kept by | Where at the site |
|---|---|---|
| Sponsor financial disclosure form for each investigator and subinvestigator | Sponsor; site keeps a copy if instructed | Investigator site file, with the other start-up documents |
| Updates to that form during the study and for 1 year after | Sponsor; site keeps a copy if instructed | Same section, dated |
| Institutional annual disclosure | Conflict of interest office | Not usually in the study file |
| Conflict determination and management plan | Conflict office; often shared with the IRB | Study file or regulatory binder, as the institution directs |
| Delegation records showing recusals or changed tasks | Investigator | Investigator site file |
| Clinical trial agreement and budget | Institution and sponsor | Contracts office; the essential record of the financial arrangement |
Why these exist:
- The investigator must give the sponsor accurate financial information and update it during the study and for 1 year after (21 CFR 54.4(b); 312.64(d); 812.110(d)). A dated copy shows when each update was made.
- The marketing applicant keeps investigators' financial records for 2 years after approval of the application (21 CFR 54.6(b)).
- In US federally funded research, the institution keeps records of all disclosures and its review of them for at least 3 years from the final expenditures report, or other dates specified in federal grant rules (42 CFR 50.604(i)).
- ICH E6(R3) says the financial aspects of the trial are documented in an agreement (Annex 1 §3.5), and lists the financial arrangement among the essential records generally in place before the trial starts (Appendix C).
- The investigator ensures a record is kept of the people to whom trial activities are delegated (Annex 1 §2.3.3), which is where a recusal shows up in practice.
Disclosure forms contain personal financial information. Store them where only people who need them can see them, and do not copy them into shared drives or emails beyond the route your site uses.
When to escalate
Escalate when you see something that a conflict process should know about and you are not confident it does:
- a colleague receiving gifts, payments or job offers from a sponsor or CRO whose study they work on;
- an investigator with a new interest who has not updated the sponsor or the conflict office;
- someone performing a task their management plan says they must not;
- pressure from leadership to change how a study is run or reported, from someone with a stake;
- enrollment or retention bonuses that are not in the trial's financial documentation.
You do not need proof. You need a reasonable concern, described factually.
Whom to tell, in order
- The investigator, unless the concern is about the investigator.
- Your institution's conflict of interest office or compliance office. At many institutions this office also accepts concerns about senior staff.
- The IRB or ethics committee, especially when the concern could affect participants' safety, rights or consent.
- The sponsor, through the monitor or study contact, when it affects the sponsor's financial disclosure or the reliability of data.
If you are worried about retaliation, ask your compliance office whether a confidential or anonymous route exists. Many institutions have one; your site's policy says how it works.
What happens after
For US federally funded research, a conflict that was not disclosed or managed on time leads to a retrospective review within 120 days to determine whether the research was biased (42 CFR 50.605(a)(3)), and if noncompliance appears to have biased the research, the institution must promptly notify the funding agency of the corrective action (42 CFR 50.606(a)). For FDA-regulated studies, late disclosures still have to reach the sponsor so the applicant's certification or disclosure is accurate.
Your part is to report what you saw, keep your own notes of what you reported and when, and cooperate with any review.
Self-reporting
Sometimes the late disclosure is your own. Report it as soon as you notice. A prompt, honest correction is far easier to manage than a gap found by an inspector.
In practice
A coordinator notices that a sub-investigator, who by his management plan should not assess the primary endpoint, has signed three efficacy assessments. She raises it with the principal investigator the same day. The principal investigator tells the conflict office and the monitor, the assessments are redone by the independent rater as the plan requires, and the deviation is documented.
Key takeaways
- Keep disclosures, updates, determinations, plans and delegation changes on file as your sponsor and institution direct.
- Protect disclosure forms as confidential financial information.
- Escalate a reasonable concern factually: investigator, conflict or compliance office, IRB, sponsor.
- Late disclosure, including your own, should be reported as soon as it is noticed.
References
- 21 CFR 54.4(b) and 54.6(b); 312.64(d); 812.110(d), eCFR.
- 42 CFR 50.604(i); 50.605(a)(3); 50.606(a), eCFR.
- ICH E6(R3), Step 4, 6 January 2025: Annex 1 §2.3.3, §3.5; Appendix C.