Clinical Trial Timestamp Adjustment via Server Verification
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Solution Overview
Problem
Clinical trials face challenges in accurately collecting and correcting timestamps for electronic diary entries due to issues such as time zone changes, user errors, and device clock inaccuracies, leading to unreliable data, which complicates the review and submission process.
Innovation Solution
A system that includes a client device and a server apparatus capable of generating and adjusting event timestamps, where the server determines a block of event entries with verified timestamps, adjusts the timestamps of other entries based on these, and generates tags to indicate timestamp adjustments, ensuring chronological accuracy and integrity of clinical trial data.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manual review and correction of timestamps is performed, then data accuracy can be improved, but time consumption and administrative burden increase significantly
Solution Approach 1:
The system performs preliminary timestamp verification and correction by comparing device timestamps against server timestamps before data submission. This preliminary action identifies and flags timestamp discrepancies automatically, preventing the need for manual review and significantly reducing the time required for data validation while maintaining high accuracy standards.
2Productivity
If device timestamps are used without verification, then data collection efficiency is maintained, but timestamp reliability deteriorates due to device clock inaccuracies
Solution Approach 1:
The system implements a feedback mechanism where device timestamps are continuously compared against server timestamps. When discrepancies are detected, the system automatically flags these timestamps for correction and adjusts them based on the verified server time. This feedback loop maintains both high data collection efficiency and timestamp reliability without requiring manual intervention.
3Manufacturing precision
If timestamp correction is performed manually, then data integrity can be ensured, but processing speed and productivity decrease
Solution Approach 1:
The system enables self-service timestamp correction by automatically detecting discrepancies between device and server timestamps, flagging affected records, and performing corrections without human intervention. This self-service approach ensures data integrity through systematic verification while maintaining high processing speeds, eliminating the bottleneck of manual correction.
4Measurement precision
If all timestamps are verified against server time, then timestamp accuracy is improved, but system complexity and computational overhead increase
Solution Approach 1:
The system applies local quality by verifying timestamps selectively based on their importance and the specific context. Critical timestamps related to clinical events are verified against server time with high precision, while less critical administrative timestamps use a simplified verification process. This differentiated approach maintains timestamp accuracy for essential data while reducing overall system complexity and computational overhead.
Data Source
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AI summary
A computer implemented method comprising receiving an event log corresponding to event entries of an electronic diary of a participant of a clinical trial, wherein the event log is generated in a client device, and the event log comprising an event identifier and an event timestamp for at least two event entries; determining a block of event entries within the event log, the block comprising a first event entry and a second event entry at least one of whose event timestamps are verified being correct in view of corresponding service timestamps of a server apparatus, wherein the first and the second event entry are arranged chronologically; and adjusting the event timestamp of the second event entry based on the first timestamp.