The Protocol

This states all the information relating to purpose, design and conduct of the trial. It defines which patients are eligible; which treatments are to be evaluated; how each patient's response is to be assessed; the end point for evaluating treatment and how the study will be coordinated.

Main features of a Protocol are:

Background and general aims; specific objectives; patient selection (inclusion and exclusion) criteria; diagnostic tests; treatment schedules; methods of patient response evaluation; trial design; arrangements for registration and, where appropriate, randomisation of patients; required size of study; monitoring of trial progress; forms and data handling; protocol deviations; plans for statistical analysis; admin.responsibilities parent/patient information sheets and consent forms.

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