How to write a research protocol

The starting point of every clinical study is the research protocol. This document reflects the essential aspects of the research and establishes the guidelines to be followed during it. Due to the fact that this is a very important point, in this article we want to delve more deeply into what a research protocol is, what it is used for and what information it should contain. 

What a research protocol is and what it is used for 

It is a document that contains a detailed and elaborated description of the study suggested , in such a way that it allows to obtain a global vision of every aspect related to the research to be conducted. The research protocol should be brief but, at the same time, all its sections should be written accurately so that anyone participating in the research can understand the procedures to be performed (regardless of whether he/she is a clinical investigator, a sub-investigator, a study coordinator, a nurse, a pharmacist, a monitor or an auditor). 

The language should be concise and ambiguities that may lead to future confusions between the different parts involved in the research should be avoided. 

The main objective of a research protocol is to guide the investigator and the other persons involved in the project through the elements that should be considered during the study. In short, it provides an outline of the research proposal and the procedures to be followed during its course. 

“It allows to obtain a global vision of every aspect related to the research to be conducted”.

 

Sections and information that a research protocol should contain 

A research protocol should contain the basic sections that are detailed as follows: 

• Title: It should be short (around 15 words) and accurate. It should make the study objectives clear to the reader and, if possible, it should include the key words as well as the type of patients that will be studied. 
• Summary: A brief recapitulation that should make the research objective and its rationale clear. It should also include a summary of the study inclusion and exclusion criteria, objectives and purpose, as well as the procedures and duration of the study to be conducted. 
• Background: In order to be able to propose a clinical study, first the foundations for the need to conduct that research should be laid. For this reason, this section should detail the background or problems that have been found and have led to the conduct of this study. This section may include references, data or figures of related studies, etc. 
• Rationale: The background should be followed by a scientific rationale of why it is convenient to conduct the study; i.e., the reasons that support the need to conduct that research. It is important that this section be linked with the previous one, so the reader quickly guess the reasons for the study. 
• Primary and secondary objectives: The primary objective is the purpose of the study and should be very similar to the protocol title, while the secondary objectives aim to obtain additional and more detailed information on important but less relevant aspects than the primary objective. It involves performing a detailed development of the study and the actions that will be taken. The objectives should be measurable, observable, achievable, and accurate. 
• Methodology: This section explains the procedures that will be applied to achieve the objectives of the clinical research. The techniques and procedures that will be followed, study design, variables, data collection and analysis, etc. should be detailed here. 
• Statistical plan: This part can be included in the methodology or in a different section. It should show the methods to be followed in the data analysis according to the type of variables, as well as the software that will be used for data analysis. 

 

“The primary objective is the purpose of the study and should be very similar to the research protocol title”.

 

Experior helps you to design your research protocol 

In Experior we have a long career, this is why we are the best partner to perform the procedures prior to the start of a clinical research as well as its development and completion. 

Especially, we have a great deal of experience in the research protocol design and drafting, which allows us to be very thorough in the writing and to shorten deadlines in the regulatory phase as the number of clarifications required by the regulatory authorities is diminished. In addition, we are fast and work with shorter delivery deadlines than the other CROs. 

We have to add that Experior has a clearly oriented toward the client, in such a way that we go out of our way to meet the specific needs of each client and fully customize each one of our procedures to suit their needs. Would you like to have more information about us? Contact us and we will be pleased to help you.