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Risk-Based Quality Management

30-minute intro to elluminate RBQM

Proactively Manage Risk Throughout the Clinical Trial Lifecycle

Part of the elluminate Clinical Data Cloud®, elluminate RBQM provides a single platform for all study data to support a data-driven monitoring effort that enables active oversight and improves trial compliance.

Comprehensive Risk Management

elluminate RBQM provides a broad set of capabilities to monitor and mitigate risk across all data sources from a single platform, providing a holistic view of risk and comprehensive data to feed Key Risk Indicators (KRIs).

  • Key Risk Indicators can be used based on traditional scoring definitions or by using elluminate’s Centralized Statistical Monitoring to provide advanced statistical analysis.
  • Quality Tolerance Limits (QTLs) can be defined and tracked within a study. QTLs can be configured to notify study team members when thresholds are nearing risk and the steps taken to address those risks are tracked in an auditable summary.
  • The Risk Assessment and Categorization Tool (RACT), which leverages the Transcelerate framework, is used to easily manage a global library of risk assessment questions, maintain study-specific risk tools, review risk assessments conducted, and support the overarching RBQM strategy.

Visualizations & Automated Actions

elluminate RBQM empowers end users with analytics and interactive dashboards within to proactively identify potential risks. Recommended actions are automatically generated based on risk-level and are all accessible from the global issues log, creating a seamless workflow for Data Managers & Central Monitoring Teams.

  • Visualizations and dashboards include drill-down capabilities to facilitate risk review and allow for further data exploration.
  • Risk factors can be viewed at both the site and country level. All metrics provide scoring and trend details so that shifting metrics are understood regardless of the data view.
  • End users are assigned recommended actions to ensure risks are addressed efficiently and are tracked within an auditable system.
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What is the difference between Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM)?

RBM is a strategy that uses technology, data & analytics to monitor risk and support decision-making & trial management. RBQM is a more expansive, end to end process that involves focusing on factors critical to quality and patient safety. It’s a systematic process put in place to identify, assess, control, and review risks throughout the entirety of the trial lifecycle. Our overview of elluminate RBQM further elaborates on the benefits of Risk-based Quality Management.

Is there regulatory guidance on adopting a risk-based approach to clinical trial quality management?

Yes, ICH E6 (R2) states that sponsors should develop a risk-based approach to monitoring trials and articulates sponsor oversight requirements. Additionally, guidance documents have been released by TransCelerate Biopharma to help drive adoption.

What differentiates elluminate Risk-based Quality Management from other RBQM solutions?

RBQM is part of the elluminate Clinical Data Cloud which provides real-time integration and standardization capabilities for all trial data types and formats, creating a single source of truth for all trial data, unlike other RBQM offerings, elluminate RBQM is the only offering within a platform with access to a Clinical Data Repository (CDR) and Operational Data Repository (ODR). With the platform approach, analytics silos are removed and the need to access multiple applications for high-quality data is eliminated. The holistic view of risk across data sources provides better visibility into the status of the study for all stakeholders and built-in issue integration creates a seamless workflow between data management and central monitoring teams. For further insight, consider viewing our elluminate RBQM overview.

What are the primary roles that utilize the elluminate RBQM tool?

Typically, a combination of Clinical Operations and Central Monitoring teams are the primary users however, additional roles may find RBQM useful. Data managers can use it for risk-based data review and site monitors can utilize this to better understand performance at their assigned locations. Additionally, a platform approach like elluminate RBQM serves as an advanced data management workbench for data management and data science teams for tiered data review and greater cross-function collaboration.

Does elluminate RBQM make sense for an outsourced model?

Yes, elluminate RBQM can play a very important role in an outsourced model. Beyond assessment, identification, and overview of risk at sites, elluminate RBQM ensures efficient CRO oversight using a risk-based approach.

Does the Risk Assessment and Categorization Tool (RACT) leverage the TransCelerate framework?

Yes, we have chosen to implement the Transcelerate framework for out-of-the-box capabilities, facilitating quicker time to value. However, other risk assessment frameworks can be used.

Does elluminate RBQM have Central Statistical Monitoring (CSM) capabilities?

Yes, elluminate RBQM provides the ability to configure KRIs with the option to run CSM methods on the KRIs, allowing users to identify and detect systematic data errors, anomalies, and fraud at the site level. CSM results are displayed within RBQM and allow users to investigate any sites that are outside the CSM alpha value threshold.

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