Risk Based Monitoring

TransCelerate’s Risk Based Monitoring Initiative seeks to develop a model approach for risk-based monitoring of clinical trials, with the goal to both enhance patient safety and ensure the quality of clinical data. As of January 2021, the Risk Based Monitoring Initiative is completed. There are no new deliverables or updates planned.


The Risk Based Monitoring (RBM) Initiative was established in 2012 as one of TransCelerate’s five initial projects designed to create efficient and effective solutions in the R&D industry. Clinical trial sites have varying levels of experience and quality, but conventional monitoring approaches were not designed to manage potential differences. Although regulators were urging companies to move to a risk-based approach, no well-understood methodologies existed that would have enabled organizations to successfully deploy and scale risk-based monitoring.

To enable the industry to follow the regulators’ general guidance, TransCelerate has developed model guidelines for targeted, risk-based clinical trial monitoring, ultimately aiming to improve data quality and patient safety. TransCelerate’s Risk Based Monitoring methodology can be adopted by any size organization, and adapted to any type or phase of a clinical trial.


Compared to earlier monitoring methods, like 100% source data verification (SDV), RBM can lead to increases in quality data, patient safety and efficiency. Specifically, it can enable:

  • Earlier detection of issues, with a greater focus on resolution and prevention of issue recurrence
  • Reduction in efforts expended on low-value activities through centralization and data analysis
  • Cost reductions through more focused centralized monitoring activities and targeted onsite monitoring
  • Greater compliance with Good Clinical Practice (GCP) and relevant regulatory requirements
  • A more collaborative cross functional team approach – the coordination of monitors, data managers, statisticians, medical monitors, and site staff


The resource solutions generated by the Risk Based Monitoring Initiative could lead to improvement in data quality and patient safety for clinical trials and reduction in effort expended on low-value activities. In addition, adoption of the Initiative’s approach to Risk Based Monitoring could lead to cost reductions through more focused centralized monitoring activity and targeted on-site monitoring.

Available Solutions

To find out more about our Information Materials, Methodology Papers and Initiative Updates visit our Initiative Solutions.

Related Initiatives

Quality Management System

Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative aims to explore ways to improve quality across the industry.


The eSource Initiative aimed to assist sponsors in overcoming challenges in moving towards more efficient data gathering practices to benefit patients, sites and sponsors.

Clinical Data Transparency

The Clinical Data Transparency Initiative was formed with a mission of developing a model approach for redacting privacy information found in clinical study reports and a model approach for the anonymization of patient-level data shared with the broader healthcare community.