Section 7 - Part

Summary

This chapter describes the planning process for a clinical trial. Successful clinical trials rely on scientific, clinical, and operational excellence, and discuss the example of large, global studies. Most study management models in the pharmaceutical industry rely on a study or project manager (PM). Efficient communication across the entire study team is a requisite for successful execution of clinical trials. Investigator-initiated studies often try to obtain investigational medicinal product (IMP) directly from the manufacturer at no-cost. Most project teams or PMs use a countdown approach where the main goal is identified as the final task. The FDA has established classifications for approximately 1700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. The Maintenance and Support Services Organization reviews and maintains MedDRA on a regular basis. Drafting the Statistical Analysis Plan (SAP) typically begins shortly after the protocol synopsis is finalized.