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2.11 Guidelines

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When planning a clinical trial of whatever size or complexity, it is very important to establish the ground rules. Although many of these are common‐sense based, it is very useful to have access to clear guidelines for all stages of the process. Such guidelines have been published covering a wide range of topics ranging from regulatory requirements to what a statistical referee should look for when reviewing a clinical trial manuscript for publication.

We will refer to some of these guidelines at the relevant stages later in the book. However, readers are warned that many of these are constantly being updated and it is always useful to check if the ones referred to are the most current.

Randomised Clinical Trials

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