### Question
What is the definition of approved clinical trial?


### Answer
The definition of **approved clinical trial** is as follows in *42 U.S.C. § 300gg*:

> a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition and is described in any of the following subparagraphs:


(A) Federally funded trials.—The study or investigation is approved or funded (which may include funding through in-kind contributions) by one or more of the following:


(i) The National Institutes of Health

#### Citation:
  - *42 U.S.C. § 300gg*
  - Heading: **CHAPTER 6A-PUBLIC HEALTH SERVICE > SUBCHAPTER XXV-REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE > Part A-Individual and Group Market Reforms > Subpart I-General Reform**

