CRF Correction Support System with Hash Verification
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Solution Overview
Problem
Pharmaceutical companies face challenges in accurately correcting Case Report Forms (CRFs) due to potential errors in Source Document Verification (SDV) by pharmaceutical companies, which can be incorrect and burdensome for physicians, especially when original documents are in paper form and require significant effort to verify and correct electronic data.
Innovation Solution
A system is implemented that includes a CRF management server, physician's terminal device, and pharmaceutical company employee's terminal device, which provides error detection and correction support by allowing physicians to correct CRFs without receiving correction values from pharmaceutical companies, using a hash processing unit to ensure data integrity and accuracy, and warning mechanisms to ensure correct input.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the pharmaceutical company provides correction values to the physician, then the correction task becomes easier and faster, but the accuracy of correction may decrease due to potential errors in SDV by the pharmaceutical company
Solution Approach 1:
The system introduces an intermediary verification mechanism where the physician's terminal device receives both the correction values from the pharmaceutical company and the original source documents, then performs independent verification before finalizing corrections. This intermediary step allows the system to benefit from the pharmaceutical company's correction suggestions while maintaining accuracy through independent verification against original documents.
Solution Approach 2:
The system implements a feedback loop where correction values provided by the pharmaceutical company are automatically verified against the original source documents stored in the physician's terminal device. The verification results feed back to confirm or reject corrections, ensuring that accuracy is maintained while still utilizing the efficiency of automated correction suggestions.
2Reliability
If the physician checks the original document against the CRF to correct errors, then the accuracy of correction is improved, but the workload and time required for correction increases significantly
Solution Approach 1:
The system performs preliminary actions by pre-storing scanned images or electronic copies of original source documents in the physician's terminal device before the correction phase. This preliminary preparation allows the physician to immediately access and verify original documents during correction without needing to physically search for paper records, significantly reducing the time required for verification while maintaining accuracy.
Solution Approach 2:
The system creates digital copies of original source documents and stores them in the physician's terminal device. These copies can be instantly accessed during the correction process, eliminating the need for the physician to manually handle and search through physical paper documents. This copying approach maintains verification accuracy while dramatically reducing the time and effort required for correction.
3Measurement precision
If two operators input data for each item separately for comparison, then the accuracy of data entry is improved, but the burden on physicians becomes significant
Solution Approach 1:
The system implements self-service by automatically performing the verification function that would otherwise require a second operator. The physician's terminal device automatically compares the CRF data with the stored original source documents, providing independent verification without requiring another physician to manually input and compare data. This maintains accuracy through automated verification while eliminating the burden of dual operator involvement.
Data Source
AI summary
An information correction support system includes a first information providing unit to provide first information that is input by a first user to a second user, a first information accepting unit to accept an error entry position in the first information and second information that is correct information for the input error entry that are input by the second user, an error entry position providing unit to provide the accepted error entry position to the first user without providing the accepted second information, a second information accepting unit to accept third information that is correction information for the error entry input by the first user, a correctness determination unit to determine whether the accepted third information is correctly input information based on the accepted second information, and a warning unit to warn the first user according to a determination by the correctness determination unit.