Clinical Trial Data Management System Configuration
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Solution Overview
Problem
Current clinical trial data management systems are costly and complex to design, customize, and adapt for new protocols, requiring highly skilled technology personnel and lacking scalability, which increases the time and expense of bringing medical products to market.
Innovation Solution
A designer program that uses visual cues and mechanisms like shapes for drag-and-drop configuration, allowing low-skilled designers to rapidly design, prototype, and deploy electronic data capture and data management systems, incorporating configuration files to standardize and automate the configuration of clinical trial data management systems across multiple platforms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If highly skilled technology personnel are used to adapt data capture and data management systems to new protocols, then the systems can be properly configured and customized, but the process becomes time-consuming, costly, and difficult to replicate
Solution Approach 1:
The patent uses templates that capture proven configuration patterns from previous clinical trials. These templates store pre-defined data elements, relationships, and validation rules that can be copied and reused across multiple protocols, eliminating the need to recreate configurations from scratch while maintaining accuracy through proven designs
Solution Approach 2:
The system performs preliminary configuration work by pre-defining data elements, relationships, and validation rules in templates before they are needed. This advance preparation allows rapid deployment when new protocols are initiated, as the foundational configuration work has already been completed and can be quickly adapted to specific protocol requirements
2Adaptability or versatility
If proprietary data capture and data management systems are customized for each new protocol, then the systems can meet specific protocol requirements, but the costs increase and scalability decreases
Solution Approach 1:
The patent segments the data management system into modular templates that represent discrete, reusable configuration units. Each template encapsulates specific protocol elements (data elements, relationships, validations) that can be independently selected, modified, and combined, allowing protocol-specific customization without requiring complete system redesign and reducing overall complexity
Solution Approach 2:
The templates are designed to be universal and applicable across multiple protocols and clinical trial types. A single template can serve multiple purposes by configuring different data elements and relationships based on the specific protocol requirements, eliminating the need for separate proprietary systems for each protocol while maintaining full adaptability
3Reliability
If computer programmers or system designers are deployed to adapt database and data storage systems to each protocol, then proper system configuration is achieved, but the process becomes difficult to replicate over trivial changes
Solution Approach 1:
The patent enables copying of proven configuration patterns through templates that store standardized data elements, relationships, and validation rules. These templates can be replicated across multiple protocols with minimal modification, ensuring consistent and reliable configuration while making the process easily replicable by non-expert users
Solution Approach 2:
The system enables protocol sponsors and clinical trial staff to perform their own system configuration using the template-based approach. By providing user-friendly interfaces and pre-configured templates, the system eliminates the need for external programmer intervention, making configuration reliable and easily replicable by the end users themselves
Data Source
AI summary
The present invention includes aspects of a designer program or tool for customizing a clinical trial program to a particular protocol of a particular clinical trial. The designer program includes visual cues or mechanisms for organizing trial components within the designer program in a straightforward manner such that technically low skilled designers can implement often complex trial protocols. In an embodiment, the designer program includes validation scripts that test functions, derivations, queries and the like. Moreover, use of the designer program can include development of trial libraries that can make customizations reusable, scalable, and highly efficient.