Organization of the Clinical Trial by the Sponsor
There is a standard set of start-up, ongoing monitoring, and close-out requirements and procedures for all clinical trials. These generic requirements are discussed in other books and are not the remit of this book. However, because of the nature of this therapeutic area, it is important to consider the particular extras and details that have to be evaluated, and this chapter provides an overview of these items. The sponsor needs to be aware of these items in a timely manner — all too often the novice will overlook an important detail until it becomes a critical issue. This chapter will help ensure these kinds of errors are avoided.
KeywordsVertebral Deformity Therapeutic Area Core Laboratory Established Osteoporosis Clinical Study Report
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