Glossary
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Clinical Trial:
A scientific study that tests the safety and the
effectiveness of a new medical treatment, drug or device
with study participants.
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Food and Drug Administration (FDA):
The government agency that sets guidelines
on the manufacture, testing, and use of drugs and medical devices. All drugs and
medical devices must be approved by the FDA before they can be used by the general
public.
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Informed Consent:
The complete and open discussion of all procedures, benefits,
risks, and expectations of a clinical trial between clinical investigators and potential
study participants. The FDA requires all participants to sign an informed consent form
before participating in a trial.
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Institutional review board:
A group of health care professionals from the local community. The board is responsible for seeing there is no unreasonable risk to the participant and the informed consent accurately informs the participant about his/her role in the study.
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Investigational treatment:
The drug or medical device being tested during a clinical trial.
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Pharmaceutical/biotechnology company:
A business that researches, develops, tests, manufactures, and/or sells medical drugs or devices.
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Protocol:
A detailed plan carefully designed by a clinical trial sponsor. It sets guidelines for a trial and usually involves several different trial locations.
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Sponsor:
The pharmaceutical company, research institution, or other health organization that funds a clinical trial and designs the protocol.
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