Data Reference Links for Reusing Validated Clinical Instruments

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Solution Overview

Problem

Conventional clinical research methods require time-consuming and resource-intensive validation of questionnaires for each study and translation, leading to inefficiencies and increased complexity, especially when multiple languages are involved.

Innovation Solution

A digital platform that utilizes data reference links to maintain data validation by allowing access to validated instruments without creating copies, enabling a single validation to be used across multiple studies and languages, and providing tools for efficient scheduling and translation management.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a questionnaire is validated for each study and each language, then data validation reliability is ensured, but the time and resources required increase 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 system allows a single validated instrument to serve multiple purposes through copying and translation mechanisms, eliminating the need to re-validate the same questionnaire repeatedly for different studies while maintaining validation reliability through reference link tracking.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent performs validation in advance on a master questionnaire before it is copied or translated. This preliminary validation action is then preserved and referenced across multiple instances, avoiding repeated validation processes. The system establishes the validation once beforehand and maintains it through reference mechanisms for future uses.

Inventive Principle:

Principle #10Preliminary action

2Measurement precision

If a questionnaire is validated for each language, then language-specific validation accuracy is improved, but the complexity and resources required increase

Engineering Contradiction:

Improvelanguage validation accuracyVSAvoidvalidation system complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent separates the validation process from the translation process. The master questionnaire undergoes validation once, and then separate translated versions are created from this validated master. This segmentation allows language-specific adaptations without requiring complete re-validation, reducing system complexity while maintaining translation accuracy through reference to the original validated instrument.

Inventive Principle:

Principle #1Segmentation

3Adaptability or versatility

If validated questionnaires are copied for each study, then study-specific customization is enabled, but data integrity and validation maintenance become problematic

Engineering Contradiction:

Improvestudy customization capabilityVSAvoidvalidation consistency

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The patent uses copying to create study-specific instances from a master validated questionnaire. However, it enhances this by creating reference links that track back to the original validation, ensuring that even though copies are made for different studies, the validation consistency is maintained through the reference mechanism that connects all copies to the master validated instrument.

Inventive Principle:

Principle #26Copying

4Reliability

If conventional validation methods are used for each study, then study-specific validation requirements are met, but productivity and efficiency decrease

Engineering Contradiction:

Improvestudy validation complianceVSAvoidquestionnaire deployment speed

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The patent merges multiple validation efforts into a single validation process. By creating a master validated questionnaire that serves as the source for multiple studies and languages, the system combines what would otherwise be separate validation activities into one unified validation event, significantly improving productivity while maintaining compliance through reference link tracking.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS12525325B2Systems and methods for data reference links to maintain data validation

Publication Date: 2026.01.13 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.