Clinical Trial - Safety

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

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Famous quotes containing the word safety:

    Perhaps having built a barricade when you’re sixteen provides you with a sort of safety rail. If you’ve once taken part in building one, even inadvertently, doesn’t its usually latent image reappear like a warning signal whenever you’re tempted to join the police, or support any manifestation of Law and Order?
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    A lover is never a completely self-reliant person viewing the world through his own eyes, but a hostage to a certain delusion. He becomes a perjurer, all his thoughts and emotions being directed with reference, not to an accurate and just appraisal of the real world but rather to the safety and exaltation of his loved one, and the madness with which he pursues her, transmogrifying his attention, blinds him like a victim.
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    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)