Protocol

« 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