Abstract
This chapter serves as a quick guide for the practical management of Investigational Medicinal Product (IMP) in clinical trials, which forms an integral aspect of clinical trial management. Clinical trials evaluating IMP require stringent controls of IMP and management of such will impact on the potential registration of these IMPs with the regulatory authorities. Regulations differ between countries and regulatory authorities regarding IMP management; however, we attempt to lay out the key principles within this chapter. This chapter will not be covering the regulations and management of medical devices. We encourage the reader to refer to the European Union directives for the use of medical devices in clinical trials for further information.
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