Clinical Trial UAT File Management for User–Manager Alignment
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Solution Overview
Problem
The challenge in clinical trials is the misalignment in user acceptance testing of electronic case report forms due to differing viewpoints between users and managers, leading to communication errors.
Innovation Solution
A system and method that enables bidirectional communication between users and managers through a platform providing a user acceptance test (UAT) service, allowing for the generation, storage, and management of UAT files with detailed information and a communication function, reducing misinterpretation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If bidirectional communication is implemented between user and manager, then communication efficiency is improved, but system complexity increases
Solution Approach 1:
The system is divided into distinct functional modules: user terminal for generating UAT files, server for storing and managing files, and manager terminal for reviewing files. Each module has specialized functions, reducing overall system complexity while enabling efficient bidirectional communication.
Solution Approach 2:
A server acts as an intermediary between the user terminal and manager terminal. The server stores UAT files and facilitates communication without requiring direct peer-to-peer connections, simplifying the communication architecture while maintaining efficiency.
2Loss of information
If detailed UAT file information is stored and shared, then understanding alignment between user and manager is improved, but information management complexity increases
Solution Approach 1:
The server performs multiple functions: storing UAT files, managing file metadata, facilitating communication between user and manager, and providing access control. This multi-functionality reduces the need for separate specialized systems, managing information complexity efficiently.
Solution Approach 2:
The system creates structured copies of UAT file information including metadata, comments, and review status. These copies are stored in standardized formats that facilitate easy retrieval and analysis without requiring complex original file management.
3Loss of time
If automated UAT file generation is implemented, then time consumption is reduced, but automation extent increases
Solution Approach 1:
The user terminal automatically generates UAT files with predefined structures and templates before manager review. This preliminary automation of file creation reduces manual preparation time while maintaining controlled automation levels through user-initiated generation.
Solution Approach 2:
The system provides self-service capabilities where the user terminal automatically creates and submits UAT files without requiring manual intervention for each file generation. The automated processes handle routine tasks while the system remains controllable and monitorable.
Data Source
AI summary
Provided is a user acceptance test system and a method thereof, and the user acceptance test method includes the steps of: generating a UAT file in response to a request of a user terminal; storing the UAT file and UAT file related information; generating a UAT file list page and providing the UAT file list page to the user terminal and a manager terminal; and providing the manager terminal and/or the user terminal with the UAT file, the UAT file related information, and a communication function on a detail page linked to any one among a UAT file list on the UAT file list page.