Workflow Scheduling Model Using Time and Sequence Anchors
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Solution Overview
Problem
Clinical trials face challenges in managing complex schedules and compliance with protocol documents, particularly due to the length and complexity of protocol documents, which often rely on manual systems like spreadsheets with sticky notes, leading to inconsistencies and difficulties in maintaining sequence and timing constraints across multiple research sites.
Innovation Solution
A workflow management system that uses a computer-instantiated mathematical model to represent clinical trial protocols, defining nodes, time-based anchors, sequence-based anchors, and activities, allowing for automated scheduling and adaptation based on context information and protocol events, ensuring compliance with both sequence and timing constraints.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If manual systems like spreadsheets with sticky notes are used to manage clinical trial protocols, then flexibility in adapting to different protocols is maintained, but consistency and accuracy in maintaining sequence and timing constraints deteriorate
Solution Approach 1:
The patent creates a digital copy of the clinical trial protocol in the form of a mathematical model, which can be instantiated multiple times across different sites. This digital representation ensures that all sites work from the same accurate version of the protocol, eliminating the inconsistencies that arise from manual copies like printed documents with sticky notes. The mathematical model captures all sequence and timing constraints precisely, ensuring consistent interpretation across all research sites.
Solution Approach 2:
The patent replaces the mechanical manual system (spreadsheets, sticky notes, paper protocols) with a computer-based automated system. The workflow management application automatically processes the mathematical model to generate schedules, compute time relationships, and enforce sequence constraints. This substitution eliminates human errors in manual scheduling while maintaining the adaptability to different protocols through configurable mathematical models.
2Manufacturing precision
If automated scheduling systems are implemented to improve consistency and accuracy, then compliance with protocol constraints is improved, but system complexity and difficulty of implementation increase
Solution Approach 1:
The patent creates a universal workflow management system that can handle multiple clinical trial protocols through a single platform. The mathematical model framework is designed to be protocol-agnostic, allowing different protocols to be represented using the same underlying structure. This universality reduces the need for separate automated systems for each protocol, thereby managing complexity while maintaining high accuracy across diverse trial designs.
Solution Approach 2:
The patent represents protocol constraints as mathematical parameters (time-based anchors, sequence-based anchors) that can be configured without changing the underlying system structure. By parameterizing the protocol requirements, the system can adapt to different protocols by simply changing the parameter values rather than restructuring the entire system. This approach maintains accuracy while managing complexity through configurable parameters.
3Ease of operation
If manual scheduling methods are used to keep the system simple and easy to operate, then ease of operation is maintained, but productivity and efficiency in managing complex multi-site trials deteriorate
Solution Approach 1:
The patent performs preliminary actions by automatically generating the complete visit schedule for all subjects across all sites before the trial begins. The workflow management application processes the mathematical model to compute all time relationships and sequence constraints in advance, creating a comprehensive baseline schedule. This preliminary automation handles the complex calculations that would be tedious and error-prone if done manually, while the interface remains simple for users to review and approve.
Solution Approach 2:
The system enables self-service by allowing the mathematical model to automatically compute schedules, detect conflicts, and suggest resolutions without requiring manual intervention for each scheduling decision. The workflow management application autonomously processes the protocol constraints and generates compliant schedules, freeing researchers from tedious manual scheduling tasks while maintaining ease of operation through simple approval workflows.
4Reliability
If complex mathematical models with both time-based and sequence-based anchors are implemented, then compliance with protocol constraints is improved, but computational complexity and processing time increase
Solution Approach 1:
The patent segments the complex scheduling problem into two distinct types of anchors: time-based anchors and sequence-based anchors. This segmentation allows the system to process different types of constraints separately and efficiently. Time-based anchors handle temporal relationships (windows, offsets), while sequence-based anchors handle ordering relationships. By dividing the constraint satisfaction problem into manageable segments, the system achieves high compliance without excessive computational overhead.
Data Source
AI summary
A computer method of managing a workflow of scheduled nodes. The method comprises instantiating a computer instantiated mathematical model of workflow paths, wherein the mathematical model defines nodes to be scheduled, defines time-based anchors between the nodes, and sequence-based anchors between the nodes; for each workflow object, determining a workflow schedule for the workflow object by an application executing on a computer system, wherein the workflow schedule comprises a plurality of nodes and wherein the application determines the workflow schedule based on the time-based anchors and sequence-based anchors between nodes defined by the mathematical model; storing by the application context information about completion of the activities performed when performing the node associated with the workflow path of the workflow object; and changing the workflow schedule of the workflow object based on the context information about completion of the activities performed and based on the mathematical model.