Clinical test data inspection doubt management system and management method

A technology for clinical trials and data inspection, applied in the field of clinical trial data supervision and management, can solve problems such as difficulty in online inspection of clinical trial data, and achieve the effect of improving the degree of intelligence

Pending Publication Date: 2019-05-21
TIANJIN ABSOLUTE SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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

Method used

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  • Clinical test data inspection doubt management system and management method
  • Clinical test data inspection doubt management system and management method

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Embodiment 1

[0037] see figure 1 , a schematic structural diagram of a clinical trial data inspection query management system provided by an embodiment of the present invention. The clinical trial data inspection query management system provided by the embodiment of the present invention includes a clinical trial data supervision subsystem, a clinical trial database subsystem, a main control computer network subsystem, a data inspection subsystem, a data query subsystem and a data distribution subsystem.

[0038] The clinical trial database subsystem collects the clinical drug trial data entered by researchers through the clinical trial data supervision subsystem, and performs data entry and file records for the clinical drug trial data. Inspection and management; the clinical drug trial data entered in the clinical trial database subsystem will be transmitted to the main control computer network subsystem through the Internet; the connection between the main control computer network subsy...

Embodiment 2

[0065] see figure 2 , a flow chart of the clinical trial data inspection challenge management method provided by the embodiment of the present invention. The clinical trial data inspection query management method provided by the embodiment of the present invention includes the following steps:

[0066] (1) Collect the drug clinical trial data provided by the investigator; the clinical trial data supervision subsystem standardizes the data according to the clinical trial data standards, and authorizes the staff to enter the trial data in the clinical trial database subsystem;

[0067] (2) Save the entered clinical trial data in the file recording unit of the clinical trial database subsystem, and monitor or modify the record files by authorized personnel;

[0068] (3) Generate and submit data files based on clinical drug trial data, and after being confirmed by the data submission unit, the data submission unit uploads the submitted data files to the main control computer net...

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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...

Claims

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Application Information

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IPC IPC(8): G16H10/20G16H50/70
Inventor 宫玮
Owner TIANJIN ABSOLUTE SCI & TECH CO LTD
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