; or (ii) an item or service that is provided to the individual solely to satisfy data collection and analysis needs for the qualifying clinical trial and is not used in the direct clinical management of the individual. (2) Qualifying clinical trial defined (A) In general For purposes of this subsection and subsection (a)(29), the term qualifying clinical trial means 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 any other life-threatening condition and is described in any of the following clauses: (i) 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. (II) The Centers for Disease Control and Prevention. (III) The Agency for Healthcare Research and Quality. (IV) The Centers for Medicare & Medicaid Services. (V) A cooperative group or center of any of the entities described in subclauses (I) through (IV) or the Department of Defense or the Department of Veterans Affairs. (VI) A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants. (VII) Any of the following if the conditions described in subparagraph (B) are met: (aa) The Department of Veterans Affairs. (bb) The Department of Defense. (cc) The Department of Energy. (ii) The clinical trial is conducted under an investigational new drug application reviewed by the Food and Drug Administration. (iii) The clinical trial is a drug trial that is exempt from having such an investigational new drug application. (B) Conditions For purposes of subparagraph (A)(i)(VII), the conditions described in this subparagraph, with respect to a clinical trial approved or funded by an entity described in such subparagraph (A)(i)(VII), are that the clinical trial has been reviewed and approved through a system of peer review that the Secretary determines— (i) to be comparable to