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Explore the intricacies of Clinical Research Administration with our comprehensive course on Protocols and Ethics. Gain expertise in trial design, ethical considerations, regulatory compliance, and more. Prepare for a future in clinical research with practical insights and knowledge. Enroll now for a rewarding journey in advancing healthcare through responsible and ethical clinical trials.
An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration (FDA) for permission to conduct a clinical trial of a medicinal product. This module describes regulatory requirements that sponsors or sponsor-investigators must meet for successful compilation, filing and maintenance of INDs. The IND and its role are defined, and the contexts in which it is required are specified.