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You are here: Home Offices Industry Contracts Common Clinical Clinical Trial Definition For purposes of proposal submission Effective January 1, 2007

Clinical Trial Definition For purposes of proposal submission Effective January 1, 2007

Study in which human subjects are assigned to a group that receives a clinical/medical intervention (e.g. medication, clinical/medical procedure, device) and/or a control group for a clinical condition and who interact with study personnel, having provided an informed consent.

    • Clinical condition – symptom, set of symptoms or a diagnosis as determined by a qualified investigator

    • Note: Consenting to the use of a biological fluid or tissue sample only for subsequent study does not constitute a clinical trial as there is no ongoing interaction between the investigator/study personnel and the human subject
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