Whether you are just starting to dip your toes in the water or diving in deep, this state-of-the-industry report will help you determine where you stack up against your peers who have plunged into the world of Risk-Based Monitoring (RBM). This report provides the industry’s first in-depth look at how organizations are approaching RBM since 2009’s introductory evaluation conducted by the Clinical Trials Transformation Initiative (CTTI).
Conducted from June to November 2013, the results of MCC’s survey represent the experiences of nearly 50 biopharmaceutical, CRO, and academic research institutes.
While the survey was conducted prior to the release of the final “FDA Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring”, it provides insights as to how organizations are interpreting and applying RBM concepts, the types of central data analytics and e-data sources being used, and the performance metrics they are using to trigger on-site monitoring visits.
The report includes over 40 figures, tables and graphs describing the survey results.
Table of Contents:
- Executive Summary
- Putting RBM into Context: Models, Approaches, and Definitions
- Survey Methodology
- Who Has Taken the RBM Plunge and Why?
- Where and When Is RBM Being Done?
- How Are the Organizations Approaching RBM?
- Redefining RBM Techniques for Future Surveys
- What Metrics Are Being Used to Trigger On-site Monitoring Visits?
- Deep-Dive Exploration of the On-site Monitoring Visit Triggers
- Putting the Metrics and Triggers into Context
- Summary and Conclusions / Future MCC Initiatives