Adverse Event - An untoward medical occurrence in a patient enrolled in a clinical trial; it is not necessarily related to the clinical research

Blinded Medications - Products that appear identical in size, shape, color, et al so that the subject and investigators do not know which medication is being given

Blinding - Procedure in which one or more parties involved in the clinical trial are kept unaware of the treatment assignment

Concomitant Med - Current medication, other than the clinical trial drug, that the subject is taking during the course of the trial

Double-blind - Design of a study where neither the investigator or subject knows which study medication the subject is receiving during the trial

Food and Drug Administration - Agency of the US government that oversees the study of investigational drugs; it grants marketing approval of new drugs

Informed Consent - Process by which a subject voluntarily confirms his/her willingness to participate in a clinical trial

Informed Consent Form - The legal written record that documents the subject’s willingness to participate in a clinical trial

Institutional Review Board - An independent body, comprised of medical professionals and non-medical members whose responsibility is to verify the integrity of the study and to ensure that the safety, integrity, and human rights of the subjects participating in a particular clinical trial are protected

Investigational New Drug - A drug never before approved for marketing or an approved drug being tested for a new indication or use

Placebo - An inactive preparation identical in appearance to the study drug

Principal Investigator - The person responsible for the conduct of the clinical trial at a particular trial site. If a trial is conducted by a team of individuals, the principal investigator is the responsible leader of the team

Randomization - The assignment of subjects to treatment or control groups in such a way that each subject has an equal change of being assigned to each treatment group

Sponsor - An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial but do not actually conduct the investigation

Wash-out Period - A period during a clinical trial when the subject receives no active medication