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:
“The high sentiments always win in the end, the leaders who offer blood, toil, tears and sweat always get more out of their followers than those who offer safety and a good time. When it comes to the pinch, human beings are heroic.”
—George Orwell (1903–1950)
“Perhaps in a book review it is not out of place to note that the safety of the state depends on cultivating the imagination.”
—Stephen Vizinczey (b. 1933)
“Love no man in good earnest, nor no further in sport
neither, than with safety of a pure blush thou mayst in
honor come off again.”
—William Shakespeare (1564–1616)