Electronic Adverse Event Tracking System for Clinical Trials
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Solution Overview
Problem
Current systems for recording adverse events in clinical trials are cumbersome and prone to inaccuracies, particularly with paper-based methods that require retroactive data entry from handwritten notes.
Innovation Solution
A computer-implemented system and method for tracking adverse events and medical information, which includes a processing device programmed to receive user requests, search for adverse event records, receive ratings, generate event records, and store them in a log, facilitating timely and accurate data collection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If paper-based systems are used to record adverse events, then data can be captured at the point of care, but data entry is cumbersome and prone to inaccuracies
Solution Approach 1:
The patent replaces the mechanical paper-based recording system with an electronic/digital system. The interface allows providers to enter adverse event data electronically, which is then stored in a database. This substitution eliminates the need for handwritten notes and retroactive data entry, thereby improving both ease of operation and accuracy of data recording.
2Productivity
If paper-based systems are used to record adverse events, then data can be captured manually, but data entry is time-consuming and disrupts workflow
Solution Approach 1:
The electronic system replaces manual paper-based data collection, enabling faster data entry and storage. The interface allows providers to quickly record adverse events during patient visits without leaving the clinical workflow, significantly reducing the time spent on data entry compared to traditional paper methods.
3Ease of manufacture
If retroactive data entry from handwritten notes is required, then paper-based recording is feasible, but data accuracy and timeliness deteriorate
Solution Approach 1:
The system replaces the two-step process of handwritten note-taking followed by retroactive data entry with a direct electronic entry system. This eliminates transcription errors and ensures data is captured accurately at the source, improving both the feasibility and accuracy of adverse event data collection.
Data Source
AI summary
A system for tracking adverse events may include at least one processing device programmed to receive a request from a user to record an adverse event experienced by a patient; receive a search term input by the user; identify, in an adverse event database and based on the search term, at least one database record for an adverse event, wherein the at least one database record includes an adverse event type and at least one characteristic; receive, via an input field, a rating of the at least one characteristic for the patient; generate an adverse event record based on the adverse event type and the rating; and store the adverse event record in an adverse event log.