Читать книгу Randomised Clinical Trials - David Machin - Страница 72

It is a fundamental requirement to develop a formal protocol for any clinical trial and we describe in general terms the subject matter of such a protocol. The chapter focuses on the content common to all trial protocols such as the background to the trial, the basic design, the type and number potential subjects to recruit, informed consent, details of the intervention options, and other practicalities including the forms required for recording the data. We illustrate each section by extracts from activated protocols used for a variety of trials in different areas.

We also emphasise the need to check local regulations concerned with the conduct of trials and reference is made to some published guidelines to help in the protocol development process.