Clinical Trial Data Management System with Automated Validation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current systems for managing case data in clinical trials are inefficient, leading to a high volume of inquiries that require significant time and effort from users to answer, particularly due to the complexity and frequency of data input and validation processes.
Innovation Solution
A management system that includes a non-transitory storage medium with a program capable of receiving case data, referencing definition tables for criteria, and automatically determining and addressing inconsistencies, allowing for efficient management of inquiries and answers by re-performing logical checks based on user input, thereby reducing the number of inquiries and streamlining the validation process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual validation and inquiry management is used for case data, then data accuracy can be maintained through human review, but the time and effort required to manage and answer inquiries increases significantly
Solution Approach 1:
The system enables self-service by automatically validating case data against pre-defined criteria in definition tables, generating inquiries, and resolving them through automated logical checks. The management apparatus independently performs validation and inquiry management without requiring continuous human intervention, thereby maintaining data accuracy while reducing the time and effort needed for manual inquiry management.
Solution Approach 2:
The system implements feedback mechanisms where validation results automatically trigger inquiry generation, and subsequent logical checks provide feedback to determine whether inquiries are resolved. This automated feedback loop ensures data accuracy is maintained through systematic validation while eliminating the need for manual review of each inquiry, thus reducing time loss.
2Manufacturing precision
If comprehensive validation criteria are applied to all case data, then data quality and consistency are improved, but the complexity of the validation process and number of inquiries generated increases
Solution Approach 1:
The validation process is segmented into distinct criteria defined in definition tables, allowing comprehensive validation to be broken down into manageable, independently evaluable components. Each criterion can be applied systematically without overwhelming complexity, as the management apparatus processes them in an organized sequence, maintaining data quality while managing process complexity.
Solution Approach 2:
The system manages complexity by changing parameters from manual validation to automated computational validation. The definition tables store validation criteria as structured parameters that can be automatically applied, transforming a complex manual process into a systematic automated process that maintains high data quality without proportional increase in operational complexity.
3Reliability
If multiple logical checks are performed sequentially, then thorough validation is achieved, but the processing time for each case data increases
Solution Approach 1:
Validation criteria are prepared in advance in definition tables, and the system performs preliminary filtering by checking basic criteria first. This preliminary action identifies obvious issues before more complex logical checks are applied, allowing thorough validation to be achieved efficiently by avoiding unnecessary processing of data that fails basic checks.
Solution Approach 2:
The system applies partial validation by focusing logical checks on specific criteria relevant to each case data context. Rather than uniformly applying all possible checks to every data point, the system performs targeted validation based on data type and context, achieving sufficient thoroughness while improving processing speed by avoiding excessive checks.
Data Source
AI summary
A non-transitory storage medium storing a management program, the management program causing a computer to execute first receiving case data related to a result of a clinical trial; referring to a definition table storing a first criterion and a second criterion; determining whether or not the case data satisfies the first criterion or second criterion; first transmitting a first inquiry to a terminal; second transmitting a second inquiry to the terminal; second receiving a first answer to the first inquiry from the terminal, the first answer including other case data that is the case data at least a part of which is modified; third determining whether or not the other case data satisfies the second criterion; and making a second answer to the second inquiry on the basis of a result of the third determination.