Clinical Trial TFL Synchronization via Word Content Controls
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Solution Overview
Problem
Existing methods for synchronizing and updating table figure listing (TFL) content in clinical trial documents are inefficient, prone to errors, and lack a streamlined process for batch operations, leading to inconsistencies and inaccuracies in medical documents.
Innovation Solution
A method utilizing a word plugin to analyze, synchronize, and update TFL content by uploading source data, reading metadata, generating new in-text TFL, configuring content controls, and filtering/sorting data with a single click, enabling synchronization and updating of clinical study reports (CSRs).
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual copy-pasting method is used to update TFL content in clinical trial documents, then writers can insert content into documents, but it leads to inclusion of unverified or outdated information, resulting in inaccurate medical documents and inconsistencies in terminology and formatting
Solution Approach 1:
The system performs preliminary actions by automatically extracting TFL data from source documents, verifying its accuracy, and preparing it for insertion into clinical trial reports before the writer needs it. This pre-processing ensures data is ready-to-use and verified, eliminating the need for manual verification later.
Solution Approach 2:
An automated data synchronization system acts as an intermediary between the TFL source data and the clinical trial document. This intermediary automatically extracts, verifies, and inserts data, replacing the manual copy-paste process and ensuring data accuracy while reducing time consumption.
2Ease of operation
If manual copy-pasting of TFL data is performed, then writers can update documents, but it results in inconsistencies in terminology, formatting, and overall quality of medical documents
Solution Approach 1:
The system uses automated copying mechanisms that extract TFL data directly from source documents and insert it into clinical trial reports with preserved formatting and terminology. This automated copying ensures consistency across all documents while maintaining ease of updating, as the system handles the copying process automatically without manual intervention.
3Productivity
If writers manually identify and update TFL content in clinical trial documents, then they can control which content is inserted, but the process is tedious and time-consuming without a streamlined method for batch operations
Solution Approach 1:
The system performs preliminary identification of all TFL content that needs to be synchronized, prepares the data in advance, and enables batch operations. This allows writers to update multiple TFL entries simultaneously with a single action, dramatically improving productivity while reducing the time required for manual identification and updating.
Solution Approach 2:
The system implements periodic synchronization capabilities that automatically update TFL content at scheduled intervals or when source data changes. This periodic action eliminates the need for continuous manual monitoring and updating, significantly improving efficiency by automating the synchronization process.
4Reliability
If source TFL data is updated, then new information becomes available, but it is challenging to synchronize these changes into the corresponding paragraphs efficiently without manual copying
Solution Approach 1:
The system implements feedback mechanisms that automatically detect when source TFL data has been updated and trigger synchronization processes. The system monitors changes in source documents, identifies updated TFL content, and automatically propagates these changes to clinical trial reports, maintaining data consistency while simplifying the synchronization process through automated detection and response.
Solution Approach 2:
An automated synchronization intermediary monitors source TFL data for changes and efficiently propagates updates to clinical trial reports. This intermediary handles the complexity of change detection, data extraction, and insertion automatically, maintaining data consistency while reducing the perceived complexity for users through streamlined operations.
Data Source
AI summary
A method to analyse, synchronize, and update of table figure listing (TFL) content in clinical trials documents using word plugin is disclosed. The method comprises the steps of:(i) uploading TFL source data through the word plugin from a source file;(ii) reading metadata of the TFL source data from a word content control, wherein the metadata stores various configurations of TFL;(iii) generating new in-text TFL from the TFL source data with the TFL metadata;(iv) updating the new in-text TFL content to correspond to the word content control;(v) configurating the word content control in (iv); and(vi) filtering and sorting the new in-text TFL content based on the configuration of (v).


