Writing A Clinical Study Protocol As A Regulatory Document

By Fadwa Dabbah, Ph.D., Medical Writer

A few years ago, when I was a staff member in a clinical research site, I always found the study protocol to be a very dependable reference. When I needed information about the activities to be performed at each visit or how to best classify the intensity of adverse event and protocol deviations, I could always refer to the study protocol. As a medical writer at Bioforum, when I write a clinical study protocol, I have a wider perspective on the general concept of its role as a regulatory document. The study is presented using clear and unambiguous essential rules to facilitate the compliance of all study stakeholders including the Investigator, Sponsor, study coordinator, and monitor within the standards of Good Clinical Practice. Such compliance and consistency are the pillars by which new drug / biologic or medical device approvals are supported.