Productized Rules = Death of Custom Functions

In the world of Electronic Data Capture (EDC) systems, building and maintaining study databases has always been a complex and time-consuming endeavor. The most significant hurdle? Writing rules, edit checks, and their corresponding test scripts. This is where custom functions have traditionally played a crucial, albeit often cumbersome, role. But there’s a revolution brewing, and it’s driven by productized rules. This blog post delves into how this shift is poised to eliminate the need for custom functions and dramatically improve the efficiency of EDC system design.

Introduction: The Old Way vs. The New Paradigm

For years, EDC system developers have relied on custom functions to implement complex data validation and edit checks. This approach, while powerful, comes with significant drawbacks:

• Time-Intensive: Creating, testing, and debugging custom functions is a time-consuming process.
• Complex Maintenance: Maintaining custom functions, especially across multiple studies or versions, adds complexity and requires specialized expertise.
• Increased Risk: Errors in custom functions can lead to data integrity issues, potentially impacting study results.

However, a new paradigm is emerging. Advanced study design environments are now offering users the ability to configure most edit checks and create complex rules directly within the system. This allows for a more streamlined, user-friendly, and efficient way to manage data validation.

The Rise of Productized Rules

The key to this transformation is the rise of “productized rules.” Instead of relying on custom code, these systems provide a powerful rules engine, allowing you to:

• Configure Rules Visually: Create edit checks and data validations using a visual interface, eliminating the need for coding knowledge.
• Leverage Pre-built Logic: Utilize pre-defined rules and functions, saving time and reducing the potential for errors.
• Improve Collaboration: Facilitate collaboration between study designers, data managers, and programmers, as rules are easier to understand and modify.
• Accelerate Study Build: Significantly reduce the time required to build and validate study databases.

Veeva’s Role in this Transformation

Veeva is at the forefront of this evolution, transforming the study build process with an advanced study design environment. Their approach empowers users to configure most edit checks and use a powerful rules engine for creating rules and advanced checks within the system, without the need for external coding. This represents a significant leap forward in EDC system design.

Benefits of Productized Rules

Embracing productized rules offers a multitude of benefits:

• Reduced Development Time: Significantly faster study build times.
• Lower Costs: Reduced reliance on specialized programming resources.
• Improved Data Quality: Enhanced data validation and reduced risk of errors.
• Increased Agility: Faster adaptation to changing study requirements.
• Enhanced User Experience: A more intuitive and user-friendly design process.

Conclusion: The Future is Here

The transition from custom functions to productized rules marks a pivotal moment in the evolution of EDC systems. By empowering users to configure rules and edit checks directly within the system, we are witnessing a fundamental shift towards greater efficiency, improved data quality, and reduced costs. Embrace this transformation, and you’ll be well-positioned to navigate the future of clinical research with greater speed and agility.