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Clinical test document management system and management method

A document management system and clinical trial technology, which is applied in the field of clinical trial document management system and management, can solve the problems of clinical trial data line inspection and questioning difficulties, achieve effective positioning and query, and improve the efficiency of document management

Active Publication Date: 2019-05-28
TIANJIN ABSOLUTE SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In view of this, the purpose of the present invention is to provide a clinical trial document management system and management method to alleviate the online inspection of clinical trial data existing in the prior art. difficult technical issues

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  • Clinical test document management system and management method

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Embodiment 1

[0033] see figure 1 , a schematic structural diagram of a clinical trial document management system provided by an embodiment of the present invention. The clinical trial document management system provided by the embodiment of the present invention includes: a clinical trial document coding subsystem, a clinical trial document classification storage subsystem, and a clinical trial document management subsystem; wherein, the clinical trial document management subsystem is used to collect clinical trial documents Relevant documents and data, generate clinical trial documents, and its output terminal is connected with the input terminal of the clinical trial document coding subsystem; the clinical trial document coding subsystem adopts the institutional / professional code mechanism to classify the documents and compile the corresponding Unique document identification code; the clinical trial document classification storage subsystem classifies and stores the coded documents.

[...

Embodiment 2

[0049] see figure 2 , a flowchart of a clinical trial document management method provided by an embodiment of the present invention. The clinical trial document management method that the embodiment of the present invention provides, comprises the following steps:

[0050] (1) The clinical trial document management system assigns authority to sponsors, hospital researchers, archivists, institutions and department doctors, and the system declares, manages and consults documents according to authority levels;

[0051] (2) The clinical trial application document management module in the data submission unit of the clinical trial document management subsystem receives the application for clinical trial data input submitted by the sponsor or the hospital researcher. After the application is approved, the clinical trial data management module and clinical trial The application file management module performs data entry, and submits the entered data to the file administrator for re...

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Abstract

The invention provides a clinical test document management system and a clinical test document management method, and relates to the technical field of clinical test data management. According to thetechnical scheme of the invention, the system comprises a clinical test document coding subsystem, a clinical test document classified storage subsystem and a clinical test document management subsystem. The clinical test document management subsystem is used for collecting documents and data related to clinical tests and generating clinical test documents. The clinical test document coding subsystem adopts a mechanism professional code mechanism and is used for classifying documents and compiling unique document identification codes corresponding to the documents. The clinical test document classification and storage subsystem classifies and stores the encoded documents. According to the technical scheme, the technical problem that in the prior art, clinical test data documents are difficult to inquire is solved. The effective positioning and inquiring of the clinical test data and the documents are achieved. The document management efficiency of clinical test related personnel is improved, and the clinical test related personnel can conveniently sort and classify the clinical test data.

Description

technical field [0001] The invention relates to the technical field of clinical trial data management, in particular to a clinical trial document management system and management method. Background technique [0002] With the continuous advancement of medical clinical technology, more and more clinical trials are recognized, and the medical structure also encourages medical researchers to break through the conventional mouse test in the drug test stage, and recruit subjects according to the requirements and characteristics of the clinical trial project. In clinical trials, it is helpful for breakthroughs in drug research results. There are many links in the clinical trial process, which are mainly divided into four stages, namely, the application and approval process of clinical trial projects, the recruitment of subjects and physical and chemical examination, the admission of subjects to the hospital for clinical trials, and the data collation after the trial is completed. ...

Claims

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Application Information

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IPC IPC(8): G16H10/20G06F16/93
Inventor 宫玮
Owner TIANJIN ABSOLUTE SCI & TECH CO LTD
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