Medical study design/protocol

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.