42 CFR § 11.6 - What are the requirements for the submission of truthful information?

---
identifier: "/us/cfr/t42/s11.6"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 11.6 - What are the requirements for the submission of truthful information?"
title_number: 42
title_name: "Public Health"
section_number: "11.6"
section_name: "What are the requirements for the submission of truthful information?"
chapter_name: "PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL PROVISIONS"
part_number: "11"
part_name: "CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION SUBMISSION"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 282(i); 42 U.S.C. 282(j); 5 U.S.C. 301; 42 U.S.C. 286(a); 42 U.S.C. 241(a); 42 U.S.C. 216(b)."
regulatory_source: "81 FR 65138, Sept. 21, 2016, unless otherwise noted."
cfr_part: "11"
---


# 11.6 What are the requirements for the submission of truthful information?

The clinical trial information submitted by a responsible party under this part shall not be false or misleading in any particular. A responsible party who submits false and/or misleading information is subject to civil monetary penalties and/or other civil or criminal remedies available under U.S. law.