Identify Study Risks with CluePoints' Customizable RACT

As part of its commitment to providing the industry with the definitive Integrated Quality Risk Management Platform, CluePoints’ customizable Risk Assessment Categorization Tool (RACT as defined by TransCelerate) is designed to allow users to determine a risk mitigation plan for studies. The intuitive interface makes it easy to identify, interpret, and document study risk factors and is designed to specifically serve the requirements obligated of sponsors under ICH E6 (R2) (Section 5.0.2).

Risk Evaluation

ICH E6 (R2) (5.0.3) states that sponsors should evaluate identified risks by considering:

  • The likelihood of errors occurring
  • The extent to which such errors would be detectable
  • The impact of such errors on human subject protection and reliability of trial results

CluePoints Risk Assessment functionality allows users to evaluate all risks using this exact approach.

Risk Control

ICH E6 (R2) (5.0.4) requires that “The sponsor should decide which risks to reduce and/or which risks to accept.” and “Predefined quality tolerance limits should be established, taking into consideration the medical and statistical characteristics of the variables as well as the statistical design of the trial,”.

CluePoints allows users of its Risk Assessment tool to define mitigations including Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) for identified risks.

Risk Communication

ICH E6 (R2) (5.0.5) insists that the sponsor should document and communicate quality management activities to those who are involved in or affected by such activities, to facilitate risk review and continual improvement during clinical trial execution.

The CluePoints Risk Assessment tool is designed to be interactive and allows users to work together collaboratively within the platform to document and review all elements of risk. It is possible to ultimately generate a PDF list of actionable items to share with your team.

Risk Review

Section 5.0.6 obliges that the “sponsor should periodically review risk control measures to ascertain whether the implemented quality management activities remain effective and relevant, taking into account emerging knowledge and experience.”

CluePoints software is designed to enable users to regularly review the risks identified and how they should be mitigated with a view to making new decisions as the study evolves and new risks may be evident.

Risk Reporting

Section 5.0.7 of ICH E6 (R2) mandates that “the sponsor should describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken”.

CluePoints allows users to document all potential risk items and the decisions as to why they have been identified. The platform also documents all anomalies and how risks have been mitigated and eradicated. In future all elements of risk reporting will be tied together in a single document that can be submitted as part of a regulatory submission.

Risk Evaluation

ICH E6 (R2) (5.0.3) states that sponsors should evaluate identified risks by considering:

  • The likelihood of errors occurring
  • The extent to which such errors would be detectable
  • The impact of such errors on human subject protection and reliability of trial results

CluePoints Risk Assessment functionality allows users to evaluate all risks using this exact approach.

Risk Control

ICH E6 (R2) (5.0.4) requires that “The sponsor should decide which risks to reduce and/or which risks to accept.” and “Predefined quality tolerance limits should be established, taking into consideration the medical and statistical characteristics of the variables as well as the statistical design of the trial,”.

CluePoints allows users of its Risk Assessment tool to define mitigations including Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) for identified risks.

Risk Communication

ICH E6 (R2) (5.0.5) insists that the sponsor should document and communicate quality management activities to those who are involved in or affected by such activities, to facilitate risk review and continual improvement during clinical trial execution.

The CluePoints Risk Assessment tool is designed to be interactive and allows users to work together collaboratively within the platform to document and review all elements of risk. It is possible to ultimately generate a PDF list of actionable items to share with your team.

Risk Review

Section 5.0.6 obliges that the “sponsor should periodically review risk control measures to ascertain whether the implemented quality management activities remain effective and relevant, taking into account emerging knowledge and experience.”

CluePoints software is designed to enable users to regularly review the risks identified and how they should be mitigated with a view to making new decisions as the study evolves and new risks may be evident.

Risk Reporting

Section 5.0.7 of ICH E6 (R2) mandates that “the sponsor should describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken”.

CluePoints allows users to document all potential risk items and the decisions as to why they have been identified. The platform also documents all anomalies and how risks have been mitigated and eradicated. In future all elements of risk reporting will be tied together in a single document that can be submitted as part of a regulatory submission.