What are the regulations governing the clinical trials of drugs?

In New York, the clinical trials of drugs are heavily regulated to ensure patient safety and ethical research practices. These regulations fall under the oversight of the U.S. Food and Drug Administration (FDA), and the New York State Department of Health (DOH). The FDA has a set of guidelines known as the Good Clinical Practice (GCP) that must be followed by people conducting clinical research on drugs. This includes the need to have an Institutional Review Board (IRB) in place to review protocols for patient safety and other ethical considerations. The IRB must be comprised of at least five members and must be appointed by an appropriate authorities. The DOH has additional regulations that must be followed, including the need for informed consent from all participants in a drug trial, and the need to register the trial with the New York State Clinical Trials Registry (CTR). The CTR also requires that researchers submit reports of adverse events, side effects, and other relevant information related to the trial. The regulations in place are there to protect the rights of those participating in drug trials. It is important that everyone involved in the trial is aware of the risks involved and that they are willing to take them on behalf of their health. This helps to ensure that the trial is done in an ethical manner and results in a safe and effective drug for the public.

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What are the regulations governing the clinical trials of drugs?

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