What is a clinical trial protocol?

A clinical trial protocol is a comprehensive plan that outlines the study’s objectives, design, methodology, statistical considerations, and organisation. It specifies: 

• The purpose of the study 

• Eligibility criteria for participants 

• Details of tests, procedures, medications, and dosages 

• The schedule of activities 

• Information to be collected about participants 

This protocol ensures the study is conducted consistently and safely across all participants.