# 42 CFR § 11.42: For which applicable clinical trials must clinical trial results information be submitted?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-42-11.42

## Section

- **Citation:** 42 CFR § 11.42
- **Heading:** For which applicable clinical trials must clinical trial results information be submitted?
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 42—Public Health > CHAPTER I—PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER A—GENERAL PROVISIONS > PART 11—CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION SUBMISSION > Subpart C—Results Information Submission

## Text

(a) Applicable clinical trials for which the studied product is approved, licensed, or cleared by FDA. Unless a waiver of the requirement to submit clinical trial results information is granted in accordance with § 11.54, clinical trial results information must be submitted for any applicable clinical trial for which the studied product is approved, licensed, or cleared by FDA for which submission of clinical trial registration information is required in accordance with the following:
(1) If the primary completion date is before January 18, 2017, the responsible party must submit the clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)); or
(2) If the primary completion date is on or after January 18, 2017, the responsible party must submit the clinical trial results information specified in § 11.48.
(b) Applicable clinical trials for which the studied product is not approved, licensed, or cleared by FDA. Unless a waiver of the requirement to submit clinical trial results information is granted in accordance with § 11.54, clinical trial results information specified in § 11.48 must be submitted for any applicable clinical trial with a primary completion date on or after January 18, 2017 for which clinical trial registration information is required to be submitted and for which the studied product is not approved, licensed, or cleared by FDA.

## Nearby sections

- [42 CFR § 11.2 § 11.2 What is the purpose of this part?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.2.md)
- [42 CFR § 11.4 § 11.4 To whom does this part apply?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.4.md)
- [42 CFR § 11.6 § 11.6 What are the requirements for the submission of truthful information?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.6.md)
- [42 CFR § 11.8 § 11.8 In what format must clinical trial information be submitted?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.8.md)
- [42 CFR § 11.10 § 11.10 What definitions apply to this part?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.10.md)
- [42 CFR § 11.20 § 11.20 Who must submit clinical trial registration information?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.20.md)
- [42 CFR § 11.22 § 11.22 Which applicable clinical trials must be registered?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.22.md)
- [42 CFR § 11.24 § 11.24 When must clinical trial registration information be submitted?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.24.md)
- [42 CFR § 11.28 § 11.28 What constitutes clinical trial registration information?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.28.md)
- [42 CFR § 11.35 § 11.35 By when will the NIH Director post clinical trial registration information submitted under § 11.28?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.35.md)
- [42 CFR § 11.40 § 11.40 Who must submit clinical trial results information?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.40.md)
- [42 CFR § 11.42 § 11.42 For which applicable clinical trials must clinical trial results information be submitted?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.42.md)
- [42 CFR § 11.44 § 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.44.md)
- [42 CFR § 11.48 § 11.48 What constitutes clinical trial results information?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.48.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-42-11.42. Check the current official text before relying on it. Not legal advice.