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The protocol of a clinical trial is a document that contains:

    • The objectives (aims) of the trial
    • The trial design, including:
        • How participants will be selected;
        • How many participants are needed;
        • What measurements and endpoints will be used; and
        • How bias will be minimised
    • How the safety of people taking part, and the privacy of their data, will be ensured
    • How the data will be analysed
    • How the study will be reported


The protocol is of critical importance to the conduct of a clinical trial; it is referred to frequently throughout the trial and the medicines development process as a whole.

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