Adverse Event Data Capture System with Automated Alert Feedback

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Solution Overview

Problem

There is a need for efficient tools to capture and timely report adverse event information by field representatives, as existing systems lack automation in ensuring compliance with regulatory requirements and prompt notification to manufacturers, especially in the pharmaceutical sector.

Innovation Solution

A computer-assisted method and system that electronically captures adverse event information through a communication link, prompting users to input data, producing alerts if information is not forwarded within prescribed time periods, and includes parsing and validation to ensure accurate reporting and compliance with regulatory standards.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual reporting of adverse events by field representatives is used, then flexibility in data collection is maintained, but timeliness and completeness of reporting deteriorates

Engineering Contradiction:

Improvecompleteness of adverse event reportingVSAvoidtime delay in reporting

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The system implements automated feedback mechanisms through alert notifications that remind field representatives to complete adverse event reports within specified timeframes. The system tracks reporting status and sends follow-up alerts to ensure timely submission, creating a closed-loop feedback system that improves both completeness and timeliness of reporting.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system enables field representatives to self-report adverse events directly through portable computing devices during or immediately after site visits. This self-service capability eliminates delays associated with manual data collection and transcription, allowing representatives to capture and submit adverse event information in real-time while maintaining the flexibility of direct observation.

Inventive Principle:

Principle #25Self-service

2Reliability

If automated alert systems are implemented to ensure timely reporting, then compliance with regulatory requirements is improved, but system complexity increases

Engineering Contradiction:

Improvecompliance with regulatory requirementsVSAvoidcomplexity of reporting system

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The system pre-configures alert thresholds, notification schedules, and compliance criteria before field representatives begin reporting. Regulatory requirements and reporting timelines are established in advance, allowing the system to automatically enforce compliance without requiring complex real-time decision-making or manual configuration during adverse event reporting.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system introduces an automated intermediary layer that mediates between field representatives and regulatory requirements. This intermediary handles the complexity of compliance monitoring, alert generation, and reporting tracking, while presenting a simplified interface to users. The intermediary absorbs system complexity rather than requiring it to be exposed to end users.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Loss of time

If field representatives capture adverse event information during site visits, then timeliness of data collection is improved, but accuracy and validation of information deteriorates

Engineering Contradiction:

Improvetime to capture adverse event informationVSAvoidaccuracy of adverse event information

Core Design Contradiction:

Loss of timeVSMeasurement precision

Solution Approach 1:

The system pre-populates adverse event report forms with relevant patient information, product details, and visit data collected during the site visit. This preliminary action allows field representatives to quickly capture additional adverse event specifics without manual data entry, reducing time delays while maintaining accuracy through pre-validated baseline information.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system replaces manual verification and validation processes with automated electronic checks. The computer system automatically validates captured adverse event information against predefined criteria, checks for completeness, and flags inconsistencies. This mechanical substitution of automated validation for manual review improves both speed and accuracy of information verification.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS10263871B2Adverse event data capture and alert systems and methods

Publication Date: 2019.04.16 PURDUE PHARMA LP

AI summary

Electronic capture of adverse event information includes selective input of adverse event information into a machine in response to prompt provided to the user based on a site visit. Such adverse event information is forwardable to a location over a communication link. The machine produces one or more alerts, if adverse event information has been input, after a prescribed period of time has transpired unless the machine is informed that the same information has already been forwarded to the location. In a preferred embodiment, the customer is a clinician. Optionally, received adverse event information can be parsed to audit whether any of the information, in fact, concerns an adverse event. Systems and software concerning related technological improvements are disclosed.