A clinical trial needs a carefully structured, written plan in order not only to ensure its smooth running and successful conclusion but also to gain the compulsory agreement of an ethical committee. Such a plan is called a protocol. It consists of several stages. These are:
1 An introduction;
2 A statement of aims, objectives, hypotheses and the calculation of sample size;
3 A detailed account of the methodology, which itself is divided into a number of sections including the methods used in the statistical analysis of the data;
4 A study schedule and costing;
5 Any necessary appendices; and
6 A supporting bibliography.
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