Definitions
Protocol - The protocol is a document that states the methods and conditions under which a clinical trial is to be performed and managed.
Informed Consent - Informed consent refers to a process whereby the participant is given full information about the trial including all procedures, all potential benefits, risks and side effects.
Randomized - Method of assigning participants to treatment or control groups via a random (unpredictable) process in order to obtain equal, comparable treatment groups and prevent bias.
Double/Single-Blind - A Single-blind study is one in which the participant is unaware of which treatment they are receiving, yet the investigator is aware.
A Double-blind study is one in which neither the participant nor the investigators know what treatment the participant is receiving.
Placebo-Controlled - In placebo-controlled studies, a percentage of participants will receive a placebo, which is an inactive substance made to appear identical to the active drug.
Multi-Centered - A Multi-Centered trial is conducted under a single protocol but at more than one investigational site and by more than one investigator.
Inclusion & Exclusion Criteria - Inclusion criteria are requirements prospective participants must meet to be eligible for participation in a study. Exclusion criteria are a list of conditions, any one of which will exclude a potential participant from a study.