The MCC Risk Assessment & Mitigation Management Tool is a Microsoft Excel®-based instrument that expands upon TransCelerate Biopharma’s Risk Assessment and Classification Tool (RACT).
It includes all phases of risk management by providing the means for:
- assessing risks,
- quantifying risks,
- mitigating risks,
- controlling risks and
- managing issues.
How it Works
RA&MMT guides assessment teams through risk identification and quantification using defined levels of probability, impact and detectability. It suggests methods of reducing high priority risks and includes a means of documenting and managing actual risk mitigation actions. Additionally, the tool suggests metrics for detecting priority risks and provides an area to document issue management. At the conclusion of the clinical trial, the file becomes an archive resource that future study teams managing similar trials can review to understand risks that were previously encountered and how they were handled.
RA&MMT integrates with other MCC quality scoring tools, such as MCC’s Protocol Development Scoring Tool (ProDevST) that gathers internal and external reviewer feedback about protocol scientific design, operational feasibility and editorial quality. ProDevST reviewer questions are already mapped to RA&MMT risk questions, making it easy to bring previously gathered protocol reviewer feedback into the risk assessment discussions. Additionally, RA&MMT draws on the full spectrum of MCC standardized performance metrics to assess, detect and manage risk.
MCC members are invited to log onto the member area access the MCC Risk resources that include a white paper, a change-management guide to implementing a risk assessment process, and information about two eLearning modules that help member organizations develop a consistent foundational understanding of risk among its resources.
- Integrate with protocol development review results
- Consolidates all phases of risk management
- Guides teams through a structured risk assessment process
- Integrates with MCC Performance Metric sets
- Risks are quantified and prioritized for assigning the appropriate level of resources to reduce and oversee them.
- Aligns with regulatory body expectations for managing risk
- High quality studies with fewer issues that consume fewer resources to address them