TransCelerate has led the way in conducting research to help sponsors and CROs identify and facilitate the implementation of solutions to drive efficient delivery of new medicines. The organization states that the adoption of Risk Assessment Categorization (RACT) in clinical trials is instrumental in the identification of potential risk factors that may impact studies, and, therefore, delay or halt regulatory submission.
TransCelerate’s methodology provides clarity regarding factors for consideration, but how can the principles be applied to clinical trials efficiently? This is where CluePoints hopes to support the spirit of the initiative. CluePoints free Risk Assessment Categorization Tool – RACT provides an online software product to allow users to identify, interpret and document the risk assessment outcomes per TransCelerate’s methodology.
The CluePoints Risk Assessment Categorization Tool – RACT – allows users to:
- Answer questions 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