Heema Desai¹ and Kaushal Kapadia²*

¹Ph.D. Clinical Research (Student), Texila American University, Mumbai, Maharashtra, India
²Ph. D. Clinical Research, A Clinical Research Professional, Mumbai, Maharashtra, India

*Corresponding Author: Kaushal Kapadia, Ph. D. Clinical Research, A Clinical Research Professional, Mumbai, Maharashtra, India.

Received: April 18, 2022; Published: May 05, 2022

Abstract

Risk Based Monitoring a demand of new era and the need for the hour, which is nothing but a perfectly defined process that assures quality of clinical trials by maintaining its standard by identifying, assessing, monitoring, and reducing the risks which can affect the safety and integrity. The key parameters which would be included under Risk Based Monitoring would include Identify critical data and processes, Perform a risk assessment, Develop a monitoring plan etc.

The study that was conducted was a survey based model and individuals only from the clinical research industry with more than 5 years of experience were allowed to fill up the survey. The received data was analysed using the type I statistical analysis (percentage method) and the results were discussed.

The complete study consisted of more than 85 questions of which four parameters are discussed here i) The first step towards transitioning to RBM approach is change in mind set and a holistic approach. ii) RBM is all about targeted, efficient and intelligent monitoring and e-consenting is an example of intelligent monitoring. iii) Incorporating quality by design at concept stage improves the protocol design and monitoring plan, and iv) As sophisticated as RBM can be and as helpful as they can be, you still cannot replace the value of people being on site. To which it was understood that acceptance towards these parameters is quiet positive from the industry experts, let it be the ones from sponsors or from CRO, With RBM experience or without RBM experience.

Keywords: Risk Based Monitoring; Monitoring Plan; Onsite Monitoring Versus RBM; Approach Towards RBM

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Citation: Heema Desai and Kaushal Kapadia. “Evaluating the Preliminary Approach of Clinical Research Professional Towards Risk Based Management". Acta Scientific Clinical Case Reports 3.6 (2022): 08-14.

Copyright: © 2022 Heema Desai and Kaushal Kapadia. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.