As discussed in this chapter, clinical trial operations encompass multiple medical and scientific disciplines. Successful clinical trial operations depend on extensive planning and appropriate application of diverse and extensive internal and external resources. Clinical trial operations are heavily regulated, and the conduct of a clinical trial is never "black and white." With any clinical trial, previously unrecognized issues and concerns may arise. Having an understanding of the regulations, pertinent guidances, disease pathogenesis and presentation, therapeutic area, clinical trial methodology, and the roles played by the various disciplines involved in clinical operations is essential to manage a clinical trial.

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