Data logic checking database and establishing method and application thereof

Abstract

The invention relates to a data logic checking database and an establishment method thereof, and a method for performing data logic checking by adopting the data logic checking database. The data logic checking database comprises a clinical test data unit and a checking specification data unit, the clinical test data unit is used for storing and managing clinical test data, the checking specification data unit is used for storing and managing checking specifications, and the checking specifications are used for carrying out logic checking on the clinical test data. According to the data logic checking database disclosed by the invention, effective management of clinical test data and checking specifications can be realized, the accuracy and integrity of the clinical test data can be ensured, a unified technical standard can be provided for integration of the clinical test data logic checking specifications, and the data logic checking efficiency is improved. The method has reference and guiding significance for data acquisition, verification and analysis of subsequent similar clinical tests.

Description

Technical field [0001] The present disclosure generally relates to the field of clinical data processing. More specifically, the present disclosure relates to a data logic verification database and its establishment method, as well as a method of data logic verification using the data logic verification database. Background technique [0002] The quality of medical clinical trial data is less than that of the test success, the main purpose of the data verification is to ensure the effectiveness and correctness of the data. [0003] In the prior art, data verification typically requires DBD personnel and DM (DataManagement) to alternate operation, repeated multiple cooperation, can be implemented. Specifically, after the DBD person creates a database in the ELECTRONIC DATA CAPTURE SYSTEM, the DM personnel generates a DVS file according to the ALS file, using the Excel file mode to record the data check specification to determine, generate DVS files; DBD personnel According to the ...

AI Technical Summary

Problems solved by technology

[0005] It can be seen that the data verification process in the existing technology is cumbersome, DM personnel and DBD personnel cannot work together, and only after the current personnel complete the work, the follow-up personnel can carry out the next operation, which consumes a lot of time and the operation method is too traditional; when EDC The database in the system is updated, the above-mentioned files are regenerated, and the work involving personnel is repeated, which greatly increases time and labor costs

In addition, the whole process of data verification is recorded and transmitted in the form of offline Excel files, which not only has the risk of data loss, but also cannot uniformly summarize and refer to the data verification specifications of previous clinical trials, and at the same time, it is impossible to analyze and archive follow-up trial data specifications

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