regulatory requirements

What are the Key Regulatory Guidelines for Clinical Trials?

Clinical trials must adhere to Good Clinical Practice (GCP) guidelines, which ensure that trials are conducted ethically and that the rights, safety, and well-being of participants are protected. Regulatory agencies require detailed protocols outlining the study design, objectives, and methodologies. Additionally, trials must be registered in publicly accessible databases, such as ClinicalTrials.gov, before they begin.

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