Risk-based monitoring: Review of the current perceptions and toward effective implementation.

Abstract

The United States Food and Drug Administration issued a guidance to industry in August 2013 on risk-based approach to monitoring. This prompted industry (sponsors and contract research organizations) to brainstorm, conceptualize, and implement risk-based monitoring (RBM) in their clinical studies and programs. The acceptance and implementation across the organizations have been variable in terms of pace and methodology. Published literature, commentaries, and views through Internet search were reviewed to understand the perceptions about RBM of different key stakeholders whose function has been significantly impacted, as these highlight ground-level challenges while implementing this major change. Some solutions are proposed to address these perceptions and challenges, as sooner than later RBM will become a way of life, given that recent ICH E6, revision 2 (November 2016) includes RBM in the document. Conceptual clarity, change management, skillset, and capacity building will be the key areas of focus to make RBM successful.