Risk-based Monitoring Working Group

The MCC Risk-based Monitoring Working Group completed it’s discussions in May 2016 when it released a list of RBM Pilot Success Metrics and a set of nineteen Site Key-Risk Indicators, thresholds, and monitoring action steps.

Beginning November 2016, the MCC launched the Central Monitoring Working Group to provide members with an opportunity to explore the emerging area of Central Monitoring.

RBM Working group explored:

  • Connections between integrated quality risk management plans, key risk indicators and RBM monitoring plans
  • How process maps help to define and visualize the RBM process
  • Risk-based monitoring approaches being to implemented across the industry
  • How MCC risk & quality tools and performance metrics can support RBM
  • How to map site risk signals to monitoring activities
  • Possible metrics to assess the success of your RBM pilots

RBM Working group output available to MCC members includes:

  • Subject Matter Expert Webinar Case Studies
  • RBM Process Map
  • RBM Wiki - Key Terms and Definitions
  • RBM Pilot Critical Success Factors
  • MCC Site key risk indicators, thresholds and monitoring action steps (v1.0)
  • MCC Analysis of the TransCelerate BioPharma, Inc’s Risk-Based Monitoring Pilot Metrics

Additional RBM-related material available to the public:

Related areas:

For additional information about joining this Working Group, please contact Customer Service

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