« Back to Glossary Index

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.

« Back to Glossary Index

Find Out More