Clinical test data inspection doubt management system and management method

Abstract

The invention provides a clinical test data inspection doubt management system and a management method and relates to the technical field of clinical test data supervision and management. According tothe technical scheme, the method comprises the steps of finding out suspected clinical test data through the risk inspection of the system by a data inspector, marking problem data as problem points,automatically summarizing the problem points into a problem list table by the system, sorting and summarizing all the marked contents in the inspection process to form a summarized list of inspectiondoubtful data after the inspection work is finished, notifying the doubtful person by the system at the same time, and distributing the inspection doubtful summarized list of the clinical test data by a distribution subsystem. If questions are not solved, new questions are sent out again until the questions related to the data are completely solved. According to the technical scheme, the technical problem that in the prior art, online inspection of clinical test data is suspected and difficult is solved. The clinical test related personnel can conduct risk judgment and suspected interventionon the test data in the clinical test process through the system.

Description

technical field [0001] The invention relates to the technical field of clinical trial data supervision and management, in particular to a clinical trial data inspection query management system and management method. Background technique [0002] The quality of clinical trial data is the basis for evaluating the results of clinical trials. In order to ensure the accuracy, reliability and scientific credibility of clinical trial results, the international community and countries around the world have issued a series of regulations, regulations and guidelines to standardize the entire process of clinical trial data management. At the same time, the development of modern new drug clinical trials and the continuous progress of science and technology, especially the development of computers and networks, have provided new technical support for the standardization of clinical trials and data management, and promoted the active exploration of clinical trials by governments and the i...

AI Technical Summary

Problems solved by technology

[0006] In view of this, the purpose of the present invention is to provide a clinical trial data inspection query management system and management method to alleviate the technical problems of online inspection of clinical trial data in the prior art.

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