Despite expert design and thoughtful planning, all studies will encounter risks and issues. How well these risks and issues are managed directly correlates to how well a study is run. But tracking issues and their mitigating actions can be a cumbersome and inefficient process.
To gather insights about how to solve this ongoing problem, we met with study teams, representatives from multiple functional areas, oversight teams and clients. See how these critical insights were used to design a flexible system centered on operational and quality excellence.
Developing a responsive system for management and tracking of clinical trial risks requires thoughtful planning and understanding of current processes, inefficiencies and the desired endpoint.
Understanding the current inefficiencies
Many issues arise throughout the duration of a trial. Quality assurance groups can audit study teams to review issues logged in a tracking system to follow progression, such as:
- When was the issue first identified as a risk?
- What mitigating actions were taken against the identified risk to try to prevent the issue?
- When was the sponsor notified?
- What types of audit procedures are in place?
- What methods are used to document risks for compliance management
Although the required documentation is complete in the system, finding the documentation sources can be difficult. Even with a clinical trial management system (CTMS), teams often use emails to escalate protocol deviations and each functional area manages their own spreadsheets, creating information silos among study teams.
Enabling greater data transparency and performing real-time trending requires a comprehensive one-stop shop for risks, actions, protocol deviations, issues and decisions (RAPID). When gathering input, our stakeholders told us they needed communication features, such as alerts and notifications, so teams can break free of their silos and function as a cohesive study team. Other requested capabilities included single sign-on to expedite the logon process, search capabilities and the ability to review and escalate issues and risks.
Enabling RAPID progress
Utilizing stakeholder feedback, we created a list of highly impactful requirements to design a new, flexible system: Xcellerate® Risk and Issue Management.
First, a one-time assessment is performed with the Covance RACT (risk assessment and categorization tool). Once the RACT is locked, all the risks flow into the Xcellerate Risk and Issue Management system. The study team can assign mitigating actions to the risk, link these actions and preserve the entire history of the risk in the system for audit trails.
A RAPID (Risks, Actions, Protocol, Deviations, Issues and Decisions) is created at a site or study level and can also be specific to a country or region. The team member who reported the RAPID is listed and can also assign the RAPID to another team member, add comments and even link it to related items. This feature enables a straightforward escalation process and allows related RAPIDs to be treated as a group so a single action can be applied to multiple sites or countries.
Integrating a suite of solutions
Additional operational efficiencies can be realized with the integrated Xcellerate suite, which combines risk review, medical review, statistical review, and the soon-to-be-released data review. Xcellerate Risk and Issue Management integrates these products and establishes a bi-directional network so any changes in the actions within the system are tracked in the central monitoring dashboard, potentially revealing signals that might indicate systemic issues. As a result, reporting and transparency are enhanced and a study team can expect comprehensive and unified trend analysis and reporting of issues and protocol deviations across a single study or portfolio of studies.
Dealing with risks and issues in a timely and appropriate fashion is critical for the success of any study. By uniting CRAs, central monitors and project managers in a central, agnostic system, Xcellerate Risk and Issue Management enables fast access to critical information and increases your team’s operational efficiency and compliance. Learn more about our clinical trial optimization solutions at www.covance.com/xcellerate.