Blinded or Masked - The situation in which the study participant, the investigator or both do not know which study treatment the participant is receiving to ensure unbiased evaluation of the study treatment.
Clinical Trial - The process by which an investigational treatment is tested in human volunteers.
Food and Drug Administration (FDA) - The American government's agency responsible for protecting the public's health by regulating the review, research and approval of investigational treatments.
Informed Consent - The process by which a potential study participant is provided with information about the study and treatment before deciding whether to participate in the trial.
Institutional Review Board (IRB) - A board, committee or other group formally designated by an institution to review biomedical research involving human subjects, In the U.S., IRB reviews the protocol, approves initiation of research and periodically reviews the conduct of research.
Investigational - A medication or treatment that has not been approved for use by the public.
Placebo - An inactive substance that may be given to a percentage of the study participants in a clinical trial to assist in evaluating the effects of the active study.
Protocol - A document that states the rationale, objectives, statistical design and methodology of the clinical trial and the conditions for performance and management.
Randomization - The process by which a study participants are randomly assigned to receive a particular study medication, dosage or placebo.
Side effects - A symptom resulting from a treatment that was not intended purpose of the treatment.