Data Object References for Clinical Program Merging
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Solution Overview
Problem
Conventional systems for clinical studies face challenges in efficiently updating and merging programs for participants, often resulting in data loss, manual handling of forms, and inefficiencies in managing program changes.
Innovation Solution
The method involves utilizing data object references to initiate, assign, and merge programs for users, including generating data objects to reference events, identifying current phases, and merging programs to determine a merged program that preserves past events while incorporating updates.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If programs are heavily tied to forms built to a particularinstance of the program, then program structure is maintained, but data loss occurs during updates and forms must be manually moved and copied
Solution Approach 1:
The patent segments the program into distinct phases (e.g., screening phase, treatment phase, follow-up phase) with separate data objects for each phase. This allows the system to maintain program structure while independently managing data for each phase, preventing data loss during updates by preserving completed phase data while incorporating new phase data.
Solution Approach 2:
The system performs preliminary actions by pre-defining all program phases and their corresponding data objects before the study begins. This preliminary structuring ensures that when program updates occur, the system knows exactly which data objects to preserve and which to update, eliminating data loss without requiring manual form handling.
2Adaptability or versatility
If forms are manually moved and copied from one version of the program to an updated version, then program updates can be implemented, but the process is inefficient and time consuming
Solution Approach 1:
The system performs self-service by automatically identifying which data objects correspond to completed phases and which correspond to upcoming phases. When a program update occurs, the system automatically merges the updated program with existing participant data by matching phase identifiers, eliminating the need for manual form movement and copying while maintaining adaptability to program changes.
Solution Approach 2:
The patent replaces the mechanical process of manually moving and copying forms with an automated computer-based system that uses data objects with unique identifiers. The system automatically matches and merges data objects between program versions based on their phase identifiers, substituting manual mechanical operations with automated digital processing that is both efficient and adaptable.
3Adaptability or versatility
If programs are updated in the middle of a study at various time points, then program flexibility is improved, but efficiently merging events with the new program becomes challenging
Solution Approach 1:
By segmenting the program into discrete phases with dedicated data objects, the system simplifies the merging process during updates. When a program is updated mid-study, the system only needs to identify which phases have changed and merge the corresponding data objects, rather than reconciling entire program versions. This segmentation reduces merging complexity while maintaining update flexibility.
Solution Approach 2:
The patent introduces data objects as intermediary elements that mediate between the program structure and participant data. Each data object serves as a mediator that stores information about specific phases and events, allowing the system to efficiently merge updated program phases with existing participant data without complex reconciliation processes.
Data Source
AI summary
A method of utilizing data object references to merge one or more programs, the method including: initiating, via a server, a session of a study for a user; assigning, via the server, a first program of the study to the user, the first program including a plurality of events divided into a plurality of phases, generating respective first data objects to reference each event in the first program; receiving a second program for the user, the second program including a plurality of second events divided into a plurality of second phases; identifying a current phase at which the user will enter the second program; generating second data objects to reference each event in the second program that occurs after the current phase; and merging the first program and the second program to determine a merged program.