What are the legal requirements for clinical trials?

Clinical trials are research studies that test treatments, medications, and preventive measures on people. According to Maryland law, before enrolling a participant in a clinical trial, the investigator must obtain informed consent. Informed consent is a process in which participants are provided with a written explanation of the trial and its risks and benefits. The signed informed consent form must be approved and kept on file to ensure participant safety. In addition, Maryland law requires that clinical trials must have an Institutional Review Board (IRB) approval process. An IRB is a committee of clinical experts and community members that review the safety and ethical standards of the clinical trial. The IRB reviews the consent form, protocols, and other materials to ensure that participants are adequately informed and protected from any potential risks. The IRB also monitors the clinical trial throughout its duration. The IRB can modify or suspend a clinical trial if any issues arise. The IRB will also inspect the trial sites and monitor the reporting of adverse events. All clinical trials must meet the standards of the IRB in order to stay in compliance with Maryland’s health care laws. Overall, clinical trials are subject to a variety of legal requirements. Maryland law requires that informed consent must be obtained prior to enrolling participants, and that the clinical trial must receive IRB approval and monitoring. Following these guidelines is necessary for a successful clinical trial.

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What are the legal requirements for clinical trials?

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