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What is a clinical research study? How am I protected?

A clinical research study, or clinical trial, is a scientific study that tests potential new or investigational medical treatments, drugs, or devices. Research studies also test new uses or comparisons of known medications. Pharmaceutical companies sponsor most studies, and all must be approved by the Food & Drug Administration, (FDA). Qualified doctors, nurses, and medical researchers conduct clinical studies.

During a clinical study, you are protected by the code of regulations of the FDA, good clinical practices, the informed consent (which outlines the goals, benefits, and risks of the study), and the institutional review board, (IRB). The IRB is made up of doctors, pharmacists, clergy and law people.



 
   
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