Definitions
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 help ensure unbiased evaluation of the study treatment
Clinical Trial - Research which an investigational treatment is tested in human volunteers
Food and Drug Administration (FDA) - the American government's agency responsible for protecting consumers and promoting health indications regulations or research
Informed Consent - The process by which a potential study participant is provided with information about a research study and treatment before deciding whether or not to participate in the trial, and after fully informed agrees to participate in the study
Institutional Review Board (IRB) - A board, committee, or other group formally designated by an institution to review research involving human subjects. In the U.S., an IRB reviews the protocol; approved initiation of research, and periodically reviews the conduct of research
Investigational - A medication or treatment that has not been approved for use by the FDA.
Placebo - An inactive substance that may be given to a percentage of the study participants instead of study drug in a clinical trial to assist in evaluating the effects of the active study treatment
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 study participants are randomly assigned to receive a particular study medication, dosage, or placebo
Side Effect - A symptom resulting from a study treatment that was not the intended purpose of the treatment.
