Risk Based Monitoring Solutions

Overview Materials

This top "Overview" section contains materials that will provide a reader who is not acquainted with RBM Methodology an overview. The best place to start is to read the Interactive Guide, The Original Position Paper or the Informational Materials. The Updates will provide the reader with additional updates about the Transcelerate RBM Initiative over a few years. To download all of TransCelerate’s solutions regarding Quality Tolerance Limits, please visit its solutions page. To download TransCelerate’s report on benchmarking RBM practices pre-COVID-19, please visit the Modernizing Clinical Trial Conduct page. As of January 2021, the Risk Based Monitoring Initiative is completed. There are no new deliverables or updates planned..

More Detailed Materials

Once you’ve familiarized yourself with the RBM Overview materials above, the “More Detailed Materials” section below will provide additional details on the topics specified.

Risk Planning and Assessment
Monitoring
- Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part I; Therapeutic Innovation & Regulatory Science, September 2014; vol. 48, 5: pp. 529-535., first published on August 5, 2014
- Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part 2; Therapeutic Innovation & Regulatory Science, January 2016; vol. 50, 1: pp. 8-14., first published on December 15, 2015
- Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials; Therapeutic Innovation & Regulatory Science, November 2014; vol. 48, 6: pp. 671-680., first published on October 9, 2014
- Site Level Risk Assessment Considerations
Data Quality
- Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations; Therapeutic Innovation & Regulatory Science, January 2016; vol. 50, 1: pp. 15-21., first published on December 16, 2015
- Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct; Therapeutic Innovation & Regulatory Science, March 2016; vol. 50, 2: pp. 144-154., first published on February 4, 2016
Technology
- Technology Considerations to Enable the Risk-Based Monitoring Methodology; Therapeutic Innovation & Regulatory Science, September 2014; vol. 48, 5: pp. 536–545., first published on August 11, 2014
- Technology Enablement Considerations (Pt 2)
Metrics
- RBM Metric Narratives
- Measuring the Impact of Risk Based Monitoring (Report)

Overview Materials

More Detailed Materials

Risk Planning and Assessment

Monitoring

Data Quality

Technology

Metrics