Clinical Trial Definition For Purposes of Proposal Submission
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
NOTE: This was effective January 1, 2007