Automatic Self-Documentation in Clinical Trial Operations System

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Solution Overview

Problem

Conventional clinical trial operations systems require significant engineering and software development efforts to translate a clinical trial protocol into a working software system, leading to high costs and long implementation times.

Innovation Solution

A mobile-native clinical trial operations system that automatically generates documents, algorithms, interfaces, and menus from initial trial protocol descriptions, using a coordinator application and portal, a trial design services module, and a composition studio with a verification engine and build engine to create user interface screens and specification documents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional clinical trial operations systems are used to translate trial protocol to working software system, then the system can be implemented with full suite of document management and interfaces, but significant engineering and software development effort (several months) is required

Engineering Contradiction:

Improvecompleteness of trial operations systemVSAvoidimplementation time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary actions by automatically generating software specifications, user interfaces, and documentation from the trial protocol design itself. The trial protocol contains pre-defined elements that are automatically translated into implementation artifacts, eliminating the need for manual software development steps and reducing implementation time from several months to a fraction of that time.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The trial operations system serves itself by automatically generating its own software specifications, user interfaces, and documentation from the trial protocol. The system uses the trial protocol design as input and automatically produces the working software system components, eliminating the need for separate engineering teams and manual development processes.

Inventive Principle:

Principle #25Self-service

2Reliability

If conventional clinical trial operations systems are used with full software development effort, then complete trial operations functionality is achieved, but high costs are incurred

Engineering Contradiction:

Improvecompleteness of trial operations systemVSAvoiddevelopment cost

Core Design Contradiction:

ReliabilityVSLoss of energy

Solution Approach 1:

The system eliminates expensive manual software development by having the trial protocol automatically generate software specifications and user interfaces. The trial protocol design serves as both the requirements document and the source code generator, eliminating the need for paid engineering teams and reducing development costs significantly while maintaining complete trial operations functionality.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The system creates copies of trial protocol elements automatically. Each element in the trial protocol (visit schedules, assessment forms, inclusion/exclusion criteria) is copied and transformed into corresponding software components (user interfaces, data collection forms, validation rules), eliminating the need for manual recreation and reducing development costs.

Inventive Principle:

Principle #26Copying

3Adaptability or versatility

If manual software development is used to create trial operations system, then customization to specific trial needs is possible, but extensive engineering teams are required

Engineering Contradiction:

Improvecustomization capabilityVSAvoidengineering team size

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system eliminates the need for extensive engineering teams by having the trial protocol automatically generate customized software specifications and user interfaces. The trial protocol itself contains all the customization information needed, and the system automatically translates it into working software components, reducing engineering team size from extensive to minimal.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

All customization decisions are made in advance during trial protocol design. The trial protocol contains pre-defined elements that automatically generate customized software components. This preliminary action eliminates the need for manual customization during implementation, reducing the complexity and size of engineering teams required.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS11594307B2Automatic self-documentation in a mobile-native clinical trial operations system and service suite

Publication Date: 2023.02.28 LABORATORY CORPORATION OF AMERICA HOLDINGS INC

AI summary

A self-documenting clinical trial operations system and service suite and method, with a clinical trial operation software, a coordinator application and coordinator portal, providing information for the clinical trial operation software, a trial design services module, examining a trial design provided by a coordinator and automatically generating a software specification for a trial operations service suite, a patient application and patient portal generated from the trial design services module, for providing patient information for the clinical trial operation software, a customization option to customize at least one of the patient application and patient portal, a specification option to generate a specification document describing a design of a coordinator-customized patient application, wherein the customization and specification options are provided to the coordinator via the coordinator portal.