; (B) items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; or (C) a service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis. (3) Information concerning clinical trials (A) In general Subject to subparagraph (B), the Secretary, in consultation with relevant stakeholders, shall develop a single standardized electronic form for use by the individual or the referring health care provider to submit to the State agency administering the State plan in order to verify that the clinical trial meets the conditions established for an approved clinical trial (as defined in subsection (c)). (B) Excluded information For purposes of subparagraph (A) or any such request by the State agency for information regarding a clinical trial, an individual or referring health care provider shall not be required to submit— (i) the clinical protocol document for the clinical trial