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MCC RBM Report 2016
MCC RBM Report 2016

MCC RBM Report 2016

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MCC Item #:RBM2016

An Updated Look at Risk Assessment and Risk-based Management Practices – A Survey of Risk Assessment Practices and a Review of Current Organizational Approaches and e-Data Sources Driving Risk-based Monitoring Programs 

Report Length:  65 Pages

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The clinical trials industry has seen Risk-Based Monitoring (RBM) move from conception to vanguard over the past decade. This change in acceptance of RBM is a key finding in an online survey conducted by Metrics Champion Consortium (MCC) between November 2015 and January 2016. The survey is a follow-up to the seminal work piloted by MCC in 2013, which was the first survey to examine organizational approaches and e-data sources driving risk-based monitoring (RBM) programs.

That earlier research documented the widespread use of RBM across all phases of trials, in all regions, on a pilot basis as well as across programs, and in pivotal trials. Specifically, in 2013, 30% of respondents reported using RBM in pivotal trials. Now, two years later, the updated survey finds that 50% of respondents are using RBM in pivotal trials, a significant shift. In addition, this report delves into how RBM approaches have evolved, the characteristics of those approaches, the types of studies in which each RBM approach is applied, reasons behind implementation of RBM programs, and the central data analytic methods being used.


New questions explore risk assessment practices and RBM program effectiveness metrics . The survey questionnaire was updated to explore  the industry’s growing use of formal risk assessment (RA) as a tool for identifying causes of risk that could affect the collecting of critical data or the performance of critical processes prior to a clinical trial and as it unfolds. Additionally, new questions gathered feedback about how company assesses (or plans to assess within a year) the effectiveness of their RBM programs.


Key Questions Explored In This Study

Section I: Risk Assessment

  • Are Organizations Conducting Formal Risk Assessments?
  • What Electronic Data Sources Do Organizations Review During Risk Assessments?
  • Why Do Organizations Conduct Risk Assessments?

Section II: Risk-based Site Monitoring

  • How Many Organizations Use a Risk-Based Approach to Site Monitoring?
  • In Which Study Phases Do Organizations Operate a Risk-Based Approach to Monitoring?
  • In Which Regions of the World Do Organizations Operate a Risk-Based Approach to Monitoring?
  • How Do Organizations Approach the Study Monitoring Process?
  • What Strategies Are Used for Reduced SDV and other Risk-based On-Site Monitoring?
  • Why Do Organizations Implement a Risk-Based Approach to Monitoring?
  • Which Electronic Data Sources Do Organizations use?
  • Which Analysis Methods Do Organizations use?
  • How Do Organizations Assess the Effectiveness of RBM Programs?

The survey contained 28 questions and represents the experiences of nearly 70 respondents at pharmaceutical, contract research organizations (CRO), biotechnology, medical device, academic research, and other institutions. The rich data gathered in the survey are presented in more than 50 charts and graphs.

Table of Contents

       Executive Summary

       RBM Models, Approaches, and Definitions

       Survey Methodology

       Section I: Risk Assessment Results

       Section II: Risk-based Site Monitoring Results


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