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42 CFR § 11.8 - In what format must clinical trial information be submitted?

---
identifier: "/us/cfr/t42/s11.8"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 11.8 - In what format must clinical trial information be submitted?"
title_number: 42
title_name: "Public Health"
section_number: "11.8"
section_name: "In what format must clinical trial information be submitted?"
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: "2026-04-05"
last_updated: "2026-04-05"
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"
---

# 11.8 In what format must clinical trial information be submitted?

Information submitted under this part must be submitted electronically to ClinicalTrials.gov, in the format specified at *https://clinicaltrials.gov* or successor site.

[81 FR 65138, Sept. 21, 2016, as amended at 89 FR 97559, Dec. 9, 2024]