A survey of risk assessment practices and a review of current organizational approaches and e-data sources driving risk-based monitoring programs
The clinical trials industry has seen Risk-based Monitoring (RBM) move from conception to vanguard over the past decade. This report highlights the industry’s change in acceptance of RBM through an online survey conducted by Metrics Champion Consortium (MCC) between November 2015 and January 2016. The survey and report 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.
In 2013, 30% of survey respondents reported using RBM in pivotal trials. Two years later, the updated survey reveals that 50% of respondents are using RBM in pivotal trials, a significant shift. 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.
Key Questions Explored in the Report:
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 report covers the survey’s 28 questions and experiences of nearly 70 respondents at sponsor organizations, CROs, academic research centers, and other institutions. The rich data gathered and analyzed are presented in 50 charts and graphs.