TRI Position Paper – Designing Risk Metrics 22Oct2013

1. Background

Triumph Research Intelligence (TRI) was founded as a subsidiary of Triumph Consultancy Services in 2013, following 12 years of consulting to the clinical trial industry. Over the past 12 months TRI has been evaluating the specific challenges facing the industry when implementing a risk-based monitoring strategy and the various approaches and products being utilized by organizations as they move into this new arena. This paper aims to summarize our findings and provide guidance as to how the main challenges can be overcome.

2. Introduction

In August 2013, the FDA published the final version of the Guidance for Industry paper, Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring1 . In this paper the FDA were clear that the recommendation to sponsors is to consider a change in approach to monitoring. The FDA goes on to state that they believe a risk-based approach to monitoring could improve sponsor oversight of clinical investigations. The paper specifically refers to the use of centralized monitoring using statistical assessments to prioritize and guide on-site monitoring visits, and that they are anticipating a decreased use of on-site monitoring as monitoring methods evolve and technical capabilities are enhanced.

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