What is a “Qualified Clinical Trial”?
A Qualified Clinical Trial is a clinical trial that is “Qualified” for coverage of routine costs under the Medicare Clinical Trial Policy by meeting both of the following criteria:
The “3 requirements”:
AND: “Deemed” to meet the additional required 7 Desirable Characteristics because it falls into one of the following:
Self-certification by the Principal Investigator was initially contemplated but never implemented by CMS and may not be used to determine whether a study qualifies for coverage.
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