Excel-Based RACTs Go To The Cloud
TransCelerate’s Risk Assessment and Categorization Tool (RACT) has exhibited usefulness with study teams and has guided organizations, such as Cancer Research UK (CRUK) to adopt their own RBM questionnaires
TransCelerate has established the industry standard for risk-based assessment tools to assist study teams with defining, categorizing and quantifying clinical trial risk. Since its release,
To elaborate, Artem Andrianov of Cyntegrity, an RBM technology enterprise, recently
In order to address these deficiencies, Andrianov, in collaboration with the RBM Consortium, developed a free technology-based RACT tool,
Free RACT: @RACT
Based on TransCelerate’s RACT tool,
Figure 1: Risk Categorization
What is particularly interesting about @RACT is that it enables study teams to standardize risk interpretation via a risk catalogue, which can reduce subjectivity; Figure 2 shows risk catalogue definitions for each subcategory under IPD risks, as delineated by a black popup box. The tool features some definitions from
Figure 2: Risk Specification
Figure 3 outlines a view for the study’s overall risk assessment once some, or all 13 risk categories are completed. This view contains overall and weighted visualizations based on risk, with high risk categories appearing as larger circles in red and vice versa for lower risk categories (in green). Study teams can also visualize IPD and risk scores for individual categories, and can generate a report delineating the entire RACT strategy. The system also contains an audit trail, assigned personnel tracking, and version control as the RACT is updated throughout the trial.
Figure 3: Overall Study Risk View
What @RACT Means for Study Teams
Reducing Subjectivity. A big challenge with Excel-based RACTs is that they does not provide specific examples of risk categorization. Implementing risk catalogs/definitions through technology can help study teams standardize their approaches towards interpreting risk on an organizational level.
Better Version Control and Collaboration. Tracking data and versions through Excel is antiquated, not validated, and poses issues with version control. Many cloud-based solutions are emerging to address the need for management to more accurately interpret and access aggregated insights. @RACT’s integrated collaborative tools and audit trails for clinical trial risk categorization allows for better version control and collaboration.
Enhanced Risk Amendments. Oftentimes (if not always) risk profiles change as a study takes course. Understanding how these risks change over time enables study teams to optimize their approaches by prioritizing risks that matter, and downgrading risks that were initially perceived as a priority. @RACT’s overall study risk categorization visualizations allow teams to compare how risks have changed over time, and gain an enhanced perspective on the bigger picture across all functions.
Easy Integration into RBM Systems and Aggregate Reporting. The beauty about technologically based systems is that they can seamlessly integrate into other systems for enhanced risk assessments, tracking, execution, and reporting.
Why is @RACT Free?
Andrianov said, “We’re offering this system for free to improve the overall risk management awareness in the industry. We have similar goals as TransCelerate to propagate proper clinical trial risk planning, but, we also want to enhance operability, quality and ease of use through our technology.”
Newsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.