Protocol
The protocol of a clinical trial is a document that contains:
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- The objectives (aims) of the trial
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- The trial design, including:
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- How participants will be selected;
- How many participants are needed;
- What measurements and endpoints will be used; and
- How bias will be minimised
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- The trial design, including:
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- How the safety of people taking part, and the privacy of their data, will be ensured
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- How the data will be analysed
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- 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.