This text of Connecticut § 38a-504b (Clinical trial criteria.) is published on Counsel Stack Legal Research, covering Connecticut primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
A clinical trial for the prevention of cancer shall be eligible for coverage only if it involves a therapeutic intervention, is a phase III clinical trial approved by one of the entities identified in this section, and is conducted at multiple institutions. In order to be eligible for coverage of routine patient care costs, as defined in section 38a-504d, a clinical trial shall be (1) conducted under the auspices of an independent peer-reviewed protocol that has been reviewed and approved by:
(A)One of the National Institutes of Health;
(B)a National Cancer Institute affiliated cooperative group;
(C)the federal Food and Drug Administration as part of an investigational new drug or device application or exemption; or (D) the federal Department of Defense or Veterans Affairs; or (2) quali
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A clinical trial for the prevention of cancer shall be eligible for coverage only if it involves a therapeutic intervention, is a phase III clinical trial approved by one of the entities identified in this section, and is conducted at multiple institutions. In order to be eligible for coverage of routine patient care costs, as defined in section 38a-504d, a clinical trial shall be (1) conducted under the auspices of an independent peer-reviewed protocol that has been reviewed and approved by: (A) One of the National Institutes of Health; (B) a National Cancer Institute affiliated cooperative group; (C) the federal Food and Drug Administration as part of an investigational new drug or device application or exemption; or (D) the federal Department of Defense or Veterans Affairs; or (2) qualified to receive Medicare coverage of its routine costs under the Medicare Clinical Trial Policy established under the September 19, 2000, Medicare National Coverage Determination, as amended from time to time. Nothing in sections 38a-504a to 38a-504g, inclusive, shall be construed to require coverage for any single institution clinical trial conducted solely under the approval of the institutional review board of an institution, or any trial that is no longer approved by an entity identified in subparagraph (A), (B), (C) or (D) of subdivision (1) of this section. See Sec. 38a-542b for similar provisions re group policies.