Handheld Device Kiosk Mode for Clinical Trial Validation
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Solution Overview
Problem
In clinical trials, handheld devices used for electronic clinical case reporting are prone to modifications that can compromise their validated operation, leading to potential interference with intended clinical trial applications and increased liability due to the need for additional validation of third-party software and equipment interfaces.
Innovation Solution
A method and system that control a handheld device to provide a home screen, start an allowable interfacing application with limited access, and return to the home screen upon meeting specific conditions, ensuring the device operates within predetermined parameters for electronic case reporting, with the ability to interface with external equipment and transmit data to back-end servers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If handheld devices are made open to modifications to improve adaptability and ease of operation, then the device can be reconfigured for different uses including gaming, but the validated operation of clinical trial applications is compromised and reliability deteriorates
Solution Approach 1:
The device is segmented into multiple operational modes: a restricted kiosk mode for clinical trial operations and an unrestricted mode for other uses. The system partitions functionality by creating distinct operational states with different access levels, allowing the same hardware to serve both clinical reliability requirements and user adaptability needs without compromising validated operations.
Solution Approach 2:
The device operates dynamically by switching between different modes (kiosk mode and unrestricted mode) based on operational context. The system can transition between these states, allowing the handheld device to adapt its behavior and access levels dynamically rather than being statically restricted, thus maintaining both reliability during clinical operations and versatility when needed.
2Adaptability or versatility
If third-party software is installed to improve adaptability and interface with external equipment, then the device can co-operate with additional tools, but the complexity increases and requires further validation
Solution Approach 1:
A controlled interface mechanism acts as an intermediary between third-party software and the clinical trial application. This intermediary layer manages communication and data exchange, allowing third-party tools to interface with the device without directly modifying or compromising the validated clinical trial software. The intermediary handles the complexity of integration while preserving the validated operation of core functions.
3Reliability
If parental control applications are installed to prevent modifications, then the device can be protected from unauthorized changes, but these applications can be easily uninstalled and do not provide sufficient security
Solution Approach 1:
The system implements preliminary protective actions by pre-configuring the device in a kiosk mode with restricted access before it is used for clinical trials. This preliminary restriction is built into the device's operational state, preventing modifications before they can occur rather than relying on post-installation parental control applications that can be easily removed. The protection is established in advance as part of the device's core operational framework.
Data Source
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AI summary
A handheld device that has a user interface equipped at least with a display. The device provides a user with a home screen on a display of the handheld device by presenting one or more electronic case reporting questionnaires or links to one or more electronic case reporting questionnaires. The device starts an allowable interfacing application if not running already. The device provides the allowable interfacing application with such limited access to the user interface that a return key is reserved to be unusable by the allowable interfacing application and again provides the user with the home screen on the display of the handheld device in response to meeting one or more return conditions.