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.
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”.
A research protocol should contain the basic sections that are detailed as follows:
“The primary objective is the purpose of the study and should be very similar to the research protocol title”.
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.
Experior continues evolving!
We completed the integration process in the NEUCA Capital Group.
From this moment…
We grow and consolidate without losing our essence.
We put at your service a new agile structure, a global coverage, an organizational
network and a parent company that gives us stability and strength to meet the
needs of commercial and non-commercial studies.
Welcome to a new era!
Because "the best way to predict the future is to build it," and that is where we are.