Episode 24: Veeva—RTSM nightmares: avoiding the common pitfalls

This video discusses common pitfalls and nightmare scenarios when implementing Randomization and Trial Supply Management (RTSM) systems in clinical trials, providing crucial lessons learned from real-world experience.

Key Takeaways:

• Criticality of UAT and Clear Specifications: A primary cause of RTSM pitfalls is insufficient planning for User Acceptance Testing (UAT), including defining participants, comprehensive test cases (happy path and negative checks), and adequate time. Equally important is establishing clear, unambiguous specifications from the outset, as misinterpretations can lead to significant rework and delays.
• Strategic Scope Management for RTSM: Teams often err by attempting to use RTSM for functions beyond its core purpose of randomization and trial supply, such as capturing extensive data points typically handled by EDC systems. This overextension adds unnecessary burden to sites, leading to frustration and potential errors.
• Proactive Validation and Role-Based Access: Ensuring data integrity requires proactive measures, such as building specific roles for unblinded statisticians to validate randomization lists, developing unique UAT scripts tailored to biostatistics, and defining robust user permissions that account for various roles (e.g., clinical project managers, inventory management, blinding/unblinding access).
• Anticipating Real-World Scenarios: System builds should extend beyond strict protocol assumptions to anticipate real-world deviations (e.g., unexpected age limits, dose changes). Building systems that are too restrictive based solely on assumed boundaries can lead to patient interruptions at sites.
• Robust Integration and Error Handling: For any integrations with adjacent systems like EDC, thorough planning for potential transmission failures, including robust error handling and backup methods, is essential to maintain seamless operations and prevent interruptions to patient care.
• Devastating Consequences of Data Errors: A real-life case study highlighted how undetected errors in randomization lists invalidated multiple Phase III studies, leading to a beneficial drug being shelved due to regulatory non-compliance, massive financial losses, workforce reductions, and profound patient impact. This underscores the absolute necessity of meticulous validation and continuous monitoring.
• Continuous Communication and Training: Regular communication among all stakeholders (sponsors, CROs, biostats, clinical teams) through kickoff meetings and ongoing discussions is vital. Additionally, user training materials should incorporate protocol-specific and system-specific requirements, not just generic instructions, to ensure users are fully equipped.