Risk Library: A Proactive Approach to Risk Management for Clinical Studies

Categorizing and centralizing cross-study, cross-functional risk data

As part of our Xcellerate® technology suite, we developed a risk library based on cross-functional input identifying the most common risks to our clinical studies, regardless of clinical phase. These common study risks became the foundation of the risk library available to users today. Over time, the library has been expanded to accommodate standard and nonstandard risks and offers enhanced filtering capabilities along with change management and maintenance support.

Purpose and Use

The risk library establishes a system of organization for risk information that can be readily accessed by study or project teams as part of the risk  management methodology. This library is supported by the risk management framework and captures standard risks that impact the organization.

Having a risk library helps facilitate discussions of risks prior to study launch and promotes consistency and risk awareness across teams and throughout the organization. Users can access the library to identify the risks that apply to their study and import them into the risk assessment categorization tool (RACT). Once imported, the study risk assessment can be modified and adapted to meet specific scenarios.

User Benefits  

User feedback has identified these key benefits:

• Reduction in time to perform risk assessments
• Reduction in issues per study
• Reduction in time to resolve issues
• Ability to identify lessons learned
• Better association of risks and related issues/actions
• A proactive versus reactive approach to risk management

In our experience, the initial effort of identifying potential risks can be reduced from 1-2 months to 2-3 weeks. We then see a reduction of issues affecting studies. If an issue does occur, the library provides insights on who needs to be notified plus actions that teams have taken historically to resolve this issue, along with helpful lessons learned.

In short, teams can identify a potential risk for a study and have appropriate mitigation plans for resolution, if needed. Response time to critical quality issues is faster and more effective with a template to follow.

COVID-19 and Business Continuity

Pandemics, natural disasters and other impediments to business continuity are vital factors in risk management. Early in the pandemic, we utilized the library to capture and communicate COVID-19 risk factors to clinical study teams. Instead of sending emails to users regarding these risks, we leveraged the risk library as an instant, central reference point and tool for identifying known factors and proactively managing study risks. This approach saved substantial time and energy on our recovery response.

Implementing Your Risk Library

A risk library must be an integral part of a risk management program, which includes these features:

Risk methodology – The library is part of an all-encompassing methodology for risk management. Populate your library with risk information specific to your organization; we provide the base functionality, and you create your roadmap to success. Make sure that your methodology will support your library. For example, if you want to capture risk-scoring information, your methodology needs a consistent risk-scoring component, with that information housed in the library for consistency across all studies.

Risk tools – Ensure that risk tools capture the information needed in your library. It is helpful to utilize a list of values (LOVs) for consistency across study teams and define clear guidance on the completion of risk tools. Your risk tools should allow for an association among risks, actions, issues and decisions for a holistic approach. Next, define how data captured flows from various risk tools into the library. We emphasize that risk tools should not be overly complicated; simpler is better to encourage adoption.

Change management – You will need to implement change management processes along with stakeholder training to support your risk methodology and library. Focus on critical areas that will drive consistent risk data to meet your study objectives, ensuring that teams understand what data you are capturing and why.   

Support structure –  A strong collaboration between business operations and technology operations is needed to ensure the library is meeting the needs of the organization.  Developing cross functional teams or user forums allows for critical feedback on improvements for the library.   

We are forming a cross-functional group of our library users to provide feedback for changes. One upcoming enhancement will be to capture actions and lessons learned associated with identified risks. When a study team using RACT or the risk and issue management (RIM) system captures lessons learned within those systems, that information will automatically be imported into the risk library upon review. The ultimate library will offer a wealth of study information and provide a complete picture – from risk through resolution.

Steven Lang has 14 years of experience in project and risk management, with significant expertise in developing and implementing project management processes and technologies. As a director of Xcellerate Customer Success, he leads the development and advancement of Xcellerate Risk and Issue Management and Xcellerate Risk Assessment Categorization Tool. His background also includes clinical trial management and project management, with a focus on risk management.