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Common Clinical Trial Terms

Clinic/Hospital – University of Illinois Hospital or any of its associated UI Health outpatient clinics

Clinical Trial – NIH Definition –A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Clinical Trial Agreement – contract between the study site and the sponsor or clinical research organization (CRO)

Coverage Analysis – a systematic review of all procedures listed in the study protocol’s schedule of events to determine which ones are ‘billable’ and where these services should be billed.Externally Sponsored Clinical Trials –research that is funded by either industry or a not for profit  agency

Informed Consent Form– IRB approved research consent document

Investigational Device Study – A medical device is considered investigational if either condition applies:

  • The device is not approved for marketing in the U.S. or
  • The device is approved for marketing but is being clinically evaluated for a new indication.
  • The Food and Drug Administration (FDA) regulates research involving medical devices (see FDA definition), as well as all aspects of device manufacturing, marketing and distribution (Code of Federal Regulations Title 21, parts 800-1299).

Investigational Drug –  A drug that is approved by the Food and Drug Administration (FDA) for testing in humans for a specified condition but not approved for commercial marketing and sale.

Principal Investigator – the primary individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research.

Research Services Billing – billing for clinical procedures or services related to a clinical trial

Research Visit – any encounter where research related interactions / interventions will occur

Sponsor – Federal, non-Federal not for profit and for profit agencies and organizations that provide funds and/or services to support research.

Sponsor Budget – contractually agreed upon provision of funds from the sponsor to cover the cost of the items and services necessary in order to conduct the research.