Common Terms

Please see below for the definitions of commonly used terms you will hear while participating in a clinical trial.

Adverse Reaction – An unwanted effect caused by the administration of drugs
Arm – Any of the treatment groups in a randomized trial
 

Blind –  A randomized trial is “blind" if the participant is not told which arm of the trial he is on (can also be double blind)
 

Clinical Investigator – A medical researcher in charge of carrying out the clinical trial's protocol (also called PI)
 

Eligibility Criteria – Summary criteria for participant selection
Endpoint – Overall outcome that the protocol is designed to evaluate
Experimental Drug – A drug that is not FDA licensed for use in humans
 

Informed Consent Document – A document that describes the rights, benefits and risks of the study participants
Institutional Review Board (IRB) – A committee of physicians, statisticians, researchers, community advocates and others that ensures that a clinical trial is ethical and that the rights of study participants are protected
 

Protocol – A study plan on which all clinical trials are based
 

Randomization – A method based on chance by which study participants are assigned to a treatment group
 

Standard of Care – Treatment regimen or medical management based on state of the art participant care (treatment guideline)
 

Toxicity – An adverse effect produced by a drug that is detrimental to the participant's health