Abstract
Clinical trial regulations ensure that the clinical studies are carried out in a transparent manner with focus on highest standards of safety. The regulatory system also provides guidance so that the trials are efficient while providing authentic and credible data on human exposure. This chapter discuss various aspects of regulations related to clinical trials in different regulated markets including approval process, good clinical practice guidelines, harmonization of clinical trial regulations, quality assurance in clinical trials, and ethical aspects including institutional review board, informed consent, pharmacovigilance, data privacy, safety of human subjects and duties and responsibilities of various stakeholders.
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