TransCelerate RBM Volume I 27JAN2014

TransCelerate’s Risk-Based Monitoring (RBM) project had a very productive year in 2013. Subsequent to publishing the Position Paper on Risk-Based Monitoring Methodology in May 2013, we have actively worked to network the concepts and embarked on piloting and/or assessing experience among companies that implemented the methodology.

The purpose of this RBM Update document is to share the following information in our continued efforts to
move the RBM methodology from concept to practice:

  • RBM methodology and revisions based on lessons learned from application of the tools
    • Lessons from the use of the Risk Assessment and Categorization Tool (RACT) to both
      identify and assess risks
    • Clarification of Source Data Verification (SDV) and Source Data Review (SDR)
  • TransCelerate RBM Pilots including a status update and a summary of FDA feedback received
    following their review of a subset of Sponsor RBM planning and implementation packets
  • Training materials developed for TransCelerate member companies including associated training
    guides
  • External engagement and a preview of additional RBM publications from TransCelerate in 2014