Validated Instrument Reuse Through Data Reference Linking

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Solution Overview

Problem

Conventional clinical research methods require time-consuming validation of questionnaires for each study and language, leading to resource waste and inefficiency.

Innovation Solution

A digital platform that allows for a single configuration and validation of instruments, utilizing data reference links to execute validated instruments without copying, enabling multiple studies to use a validated instrument efficiently.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a questionnaire is validated for each study and language, then data validation reliability is ensured, but the time and resource consumption increases significantly

Engineering Contradiction:

Improvedata validation reliabilityVSAvoidvalidation time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent creates a master validated questionnaire that can be universally applied across multiple studies and languages. The master questionnaire is validated once and then instantiated multiple times for different studies through electronic linking, eliminating the need for repeated validation processes while maintaining data reliability across all instances

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent performs the validation process in advance on a master questionnaire before it is needed for multiple studies. By completing validation beforehand and storing the validated master instrument, the system eliminates the need to repeat validation for each subsequent study or language version, significantly reducing time consumption while maintaining reliability

Inventive Principle:

Principle #10Preliminary action

2Measurement precision

If a questionnaire is validated for each language version, then measurement precision is maintained, but the complexity of the validation process increases

Engineering Contradiction:

Improvequestionnaire measurement precisionVSAvoidvalidation process complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent creates a master validated questionnaire that serves multiple language versions through electronic instantiation. The same validated master instrument is linked to multiple language versions, maintaining measurement precision across languages while avoiding the complexity of validating each language version separately through a centralized validation framework

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Reliability

If validated questionnaires are created for each study, then data integrity is ensured, but the resource consumption and cost increase

Engineering Contradiction:

Improvedata integrityVSAvoidresource consumption

Core Design Contradiction:

ReliabilityVSLoss of energy

Solution Approach 1:

The patent enables a single validated master questionnaire to serve multiple studies through electronic instantiation and linking. The master questionnaire is validated once and then reused across numerous studies without requiring additional validation resources, maintaining data integrity while dramatically reducing resource consumption and costs associated with repeated validation processes

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent creates electronic instances or copies of the validated master questionnaire for different studies and language versions. These electronic copies reference the original validated instrument, allowing unlimited replication without additional validation resources, thereby maintaining data integrity while minimizing resource consumption

Inventive Principle:

Principle #26Copying

4Reliability

If conventional validation methods are used for each study, then the validated instrument meets study-specific requirements, but the productivity of clinical research decreases

Engineering Contradiction:

Improvestudy-specific validation requirementVSAvoidclinical research productivity

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The patent creates a universal validated master questionnaire that can be instantiated for multiple studies simultaneously. This approach maintains study-specific requirements through electronic linking and configuration while eliminating the need for separate validation processes for each study, thereby significantly improving clinical research productivity by reducing validation time and enabling faster study implementation

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS20260112465A1Systems and methods for reusable validated instruments

Publication Date: 2026.04.23 ICON CLINICAL RESEARCH LTD

AI summary

Systems and methods for using data reference links to maintain data validation are disclosed. The method may include: initiating, via a trial server, a trial session for a user; determining, via the trial server, a validated instrument to be accessed for the trial session; transmitting, to an instrument library and via the trial session, a request for an instance of the validated instrument; receiving, from the instrument library, a data reference object that is operable as a data reference link to the validated instrument stored in the instrument library, such that the data reference object is operable to execute the validated instrument without generating a copy of the validated instrument; and causing a Graphical User Interface (GUI) of the trial session to operate the data reference object, such that a user device executes the validated instrument by reference.