Safety
Responsibility for the safety of the subjects in a clinical trial is shared between the sponsor, the local site investigators (if different from the sponsor), the various IRBs that supervise the study, and (in some cases, if the study involves a marketable drug or device), the regulatory agency for the country where the drug or device will be sold.
For safety reasons, many clinical trials of drugs are designed to exclude women of childbearing age, pregnant women, and/or women who become pregnant during the study. In some cases, the male partners of these women are also excluded or required to take birth control measures.
Read more about this topic: Clinical Trial
Famous quotes containing the word safety:
“If we can find a principle to guide us in the handling of the child between nine and eighteen months, we can see that we need to allow enough opportunity for handling and investigation of objects to further intellectual development and just enough restriction required for family harmony and for the safety of the child.”
—Selma H. Fraiberg (20th century)
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—Grover Cleveland (1837–1908)