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Department of Health and Human Services
Food and Drug Administration
Office of Special Health Issues
5600 Fishers Lane, (HFI-40) September 2001
Rockville, MD 20857 (FDA) 01-1294
What is a Clinical Trial?
“Clinical trial” is the scientific the Food and Drug Adminis-
term for a test or study of a tration (FDA). FDA sets the
drug or medical device in rules to make sure that
people. These tests are done to people who agree to be in the
see if the product is safe and studies are treated as safely
effective for people to use. as possible.
Doctors and other health
professionals run the tests
according to strict rules set by
The Food and Drug Administration, or
FDA, is part of the United States
government. It is FDA’s job to make
sure medical treatments are safe and
effective for people to use.
1
Why Volunteer? Why Should
Minorities and
By taking part in a clinical others better understand how Women Participate
trial, you ca
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