Initiative Resources
Initiative Resources
Download a PDF of the RBM Interactive Guide
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 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.
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
- Integrated Quality Risk Management Plan Framework (IQRMP)
- Risk Assessment and Categorization Tool (RACT) Template
- RACT Example
- Risk Indicator Library
- Predefined Tolerance Limits Framework and Recommendations (Coming Soon)
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 Framework and Recommendations (Coming Soon)
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
- Quality Report Framework and Recommendations (Coming Soon)
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)