The CluePoints RACT in action 

CluePoints has developed a Risk Assessment & Categorization Tool (RACT as defined by TransCelerate) on the Central Monitoring Platform. The Purpose of this tool is to determine a risk mitigation plan, to select appropriate KRIs and to tailor the different analyses based on the specific risks associated to the study. Users can navigate into the categories and answer the questions in term of impact, probability and detectability according the TransCelerate methodology. Moreover, additional information can be added like the impacted functional plans, the local/global impact, etc..

The CluePoints customizable Risk Assessment Categorization Tool (RACT) provides users with an intuitive cloud-based workbench to identify, interpret, and document study risk factors.

  • Questions can be answered in term of detectability, impact and likelihood in line with the TransCelerate methodology
  • Customize categories in order of impact, probability, and detectability
  • Customize category definitions, questions, and weight
  • Define reference value fields such as the impact on monitoring plans
  • Document potential risk factors and decisions
  • Define mitigations and associated KRIs for identified risks
  • Generate a PDF list of actionable items