---
kind: "section"
citation: "42 C.F.R. § 11.22"
title: "42"
number: "11.22"
heading: "Which applicable clinical trials must be registered?"
url: "https://uscodex.org/cfr/42/11.22"
---

# §11.22. Which applicable clinical trials must be registered?

- (a) **General specification.**
  - (1) Any applicable clinical trial that is initiated after September 27, 2007, must be registered.
  - (2) Any applicable clinical trial that is initiated on or before September 27, 2007, and is ongoing on December 26, 2007, must be registered.
  - (3) **Determining the date of initiation for an applicable clinical trial.** An applicable clinical trial, other than a pediatric postmarket surveillance of a device product that is not a clinical trial, is considered to be initiated on the date on which the first human subject is enrolled. A pediatric postmarket surveillance of a device product that is not a clinical trial is considered to be initiated on the date on which FDA approves the plan for conducting the surveillance.
- (b) **Determination of applicable clinical trial for a clinical trial or study initiated on or after January 18, 2017.** A clinical trial or study that, at any point in time, meets the conditions listed in paragraph [(b)(1)](#b-1) or [(2)](#b-2) of this section will be considered to meet the definition of an applicable clinical trial.
  - (1) **Applicable device clinical trial.** A clinical trial or study that meets the conditions listed in either paragraph [(b)(1)(i)](#b-1-i) or [(ii)](#b-1-ii) of this section is an applicable device clinical trial:
    - (i) The study is a pediatric postmarket surveillance of a device product as required by FDA under [section 522](/cfr/42/522.md) of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 3601](/usc/21/3601.md)).
    - (ii) **The study is a clinical trial with one or more arms that meets all of the following criteria—**
      - (A) Study Type is interventional;
      - (B) Primary Purpose of the clinical trial is other than a feasibility study;
      - (C) The clinical trial Studies a U.S. FDA-regulated Device Product; and
      - (D) **One or more of the following applies—** (1) At least one Facility Location is within the United States or one of its territories,

        (2) A device product under investigation is a Product Manufactured in and Exported from the U.S. or one of its territories for study in another country, or

        (3) The clinical trial has a U.S. Food and Drug Administration IDE Number.

  - (2) **Applicable drug clinical trial.** A clinical trial with one or more arms that meets the following conditions is an applicable drug clinical trial:
    - (i) Study Type is interventional;
    - (ii) Study Phase is other than phase 1;
    - (iii) The clinical trial Studies a U.S. FDA-regulated Drug Product; and
    - (iv) **One or more of the following applies—**
      - (A) At least one Facility Location for the clinical trial is within the United States or one of its territories,
      - (B) A drug product (including a biological product) under investigation is a Product Manufactured in and Exported from the U.S. or one of its territories for study in another country, or
      - (C) The clinical trial has a U.S. Food and Drug Administration IND Number.

## Notes

### Authority

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).

### Source

Source: 81 FR 65138, Sept. 21, 2016, unless otherwise noted.