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.

Risk Management in Clinical Trials: Assessment of Current Practices at Portuguese Clinical Trial Sites

“…Sponsors, especially industry sponsors, have intensified the risk culture implementation, for example, through the implementation of risk-based monitoring methodologies. [6][7][8] Regulatory authorities have also taken some steps in the mindset change from a conservative approach, with the objective of ensuring zero defects, to a risk-based approach by which areas of greatest risk are identified and prioritized. 2,3,9 Several guidance and consultation documents aligned with this new way of thinking have been issued by the health regulatory authorities in the beginning of the 2010s.…”