Offline Clinical Trial Data Collection With Secure Form Synchronization
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Solution Overview
Problem
Existing clinical trial data collection methods are inefficient, lack security, and are not universally accessible, leading to suboptimal data quality and privacy concerns.
Innovation Solution
A method and system utilizing a user equipment and management server for secure, efficient data collection and handling through authentication, case report form generation, updating, and synchronization, with user registration via NFC or QR codes, enabling offline data entry and secure data transmission.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If paper version of CRF is used, then data collection is simple and accessible, but extra work for digitalizing data is required
Solution Approach 1:
The patent implements electronic copies of CRF forms that can be accessed and completed on various devices. The system creates digital replicas of traditional paper forms, allowing medical practitioners to collect and store data electronically without needing physical paper forms, thereby eliminating the manual digitalization step while maintaining the simplicity and accessibility of paper-based collection.
Solution Approach 2:
The patent replaces the mechanical process of manual data transcription from paper to digital format with an automated electronic system. The mobile application and web platform automatically capture and store data in digital format, substituting the manual mechanical process of typing or scanning paper forms with automated electronic data capture and storage mechanisms.
2Productivity
If electronic version of CRF is used, then data digitalization is automated, but computer equipment must be available at each medical facility
Solution Approach 1:
The patent implements a multi-platform system that functions across various devices including mobile phones, tablets, laptops, and desktop computers. The application is designed to be universally accessible on different operating systems and device types, allowing medical practitioners to use electronic CRF forms regardless of the specific equipment available at their facility, thus maintaining high productivity without requiring standardized equipment infrastructure.
Solution Approach 2:
The patent implements a dynamic system that adapts to the available device and connectivity conditions. The application can operate in both online and offline modes, automatically adjusting its functionality based on the device's capabilities and network availability. This dynamic adaptation allows electronic CRF usage even in facilities with limited or no computer equipment, as the system can function on basic mobile devices with intermittent connectivity.
3Productivity
If electronic equipment is used for CRF, then data storage is automated, but security for sensitive health data may be insufficient
Solution Approach 1:
The patent implements a server-based intermediary architecture where sensitive health data is stored and managed on secure remote servers rather than locally on individual devices. The server acts as an intermediary between the user's device and the data storage system, providing automated data storage while maintaining enhanced security through centralized control, encryption, and access management. This separates the convenience of automated storage from the security risks of local device storage.
4Adaptability or versatility
If mixed paper and electronic CRF systems are used, then flexibility is maintained, but data quality and trial efficiency are impacted
Solution Approach 1:
The patent merges the advantages of both paper and electronic CRF systems into a unified hybrid solution. The system allows practitioners to access electronic forms on various devices while maintaining the ability to export and print forms as needed. Data collected electronically is automatically standardized and validated, ensuring consistent data quality, while the system's flexibility allows adaptation to different facility preferences and requirements, combining the best features of both approaches into a single integrated platform.
Data Source
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AI summary
Method for collecting and handling clinical trials data wherein is provided a user associated to a user equipment and a management server comprising the following steps: establishing a communication session between said user equipment and management server; at said management server, authenticating said user; at said management server, generating or retrieving one or more case report form associated to said user, said case report form comprising a plurality of information relative to a clinical trial; delivering the one or more case report form generated or retrieved to said user via said user equipment, at said user equipment, updating and/or viewing information of said one or more case report form, at said user equipment, storing said one or more case report updated; at said management server, synchronizing the content of said one or more case report form associated to said user with the content of the ones stored on the user equipment.