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Writing a Clinical Study Protocol as a Regulatory Document

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.

As a writer, I understand the responsibility placed on me in the preparation of clinical protocols. Poorly written protocols may lead to delays in the approval and initiation of clinical studies, costing the Sponsor time and money. Furthermore, an unclear protocol may cause mistakes in data collection that can, in some cases, render the study data unusable. At worst, an ambiguous protocol could jeopardize the safety of study participants if it contains unclear dosing information, unclear prophylactic treatment instructions, unclear safety exclusion criteria, etc.

Study protocols must be compliant with the ICH GCP E6 Guidelines and meet a standard that adheres to the principles of Good Clinical Practice before being submitted to the Ethics Committee or IRB. In addition, the study and its protocol should adhere to region-specific requirements. By their very nature, guidelines and regulations are very general and do not provide case-specific details or examples in order for them to cover as wide a variety of studies as possible.

It falls to us, as medical writers, to ensure that clinical protocol contents accurately convey the objectives, endpoints, design, methodology, study population, dosages, length of the study, statistical considerations, and aspects related to the organization of clinical trials. We also make sure that the clinical protocol provides a suitable related background and rationale for the specific study along with highlighting specific research questions that are addressed, taking into consideration ethical issues. The protocol also allows medical experts and sponsors to evaluate the feasibility and validity of the study design as a complete package. Experienced medical writers may contribute to these discussions from their accumulated knowledge working on different types of studies with various indications and a variety of objectives.

Written by:


Fadwa Dabbah, Ph.D.

Medical Writer