Title 42

SECTION 11.22

11.22 Which applicable clinical trials must be registered

§ 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) or (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) or (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 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3601).

(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;

(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