How is clinical trial safety ensured?

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Many protocols have been put into place when it comes to the approval of new clinical trial studies. For example, an extensive application or request for an investigational new drug (IND) must be filed with the FDA before researchers can conduct their studies of a new drug, device, or treatment in humans. The FDA is charged with approving the study’s safety before any clinical trial on a human can take place.  Research sponsors are required to give informed consent to all participants, and the study must be reviewed by an institutional review board (IRB) to ensure the trial is a moral one. They also agree to fully follow all the rules established for the study of new investigational drugs and treatments. Clinical trial research has these protocols in place in order to maintain the necessary standards for safety.

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This post was written by ClinicalTrialAdmin