Clinical testing case report table quality control system and quality control method

Abstract

The invention provides a clinical testing case report table quality control system which relates to the field of clinical testing data management technology. The system comprises a CRF quality controlplan management subsystem, a CRF quality control table management subsystem and a CRF quality control report management subsystem. According to the clinical testing case report table quality controlsystem, through acquiring clinical testing item information and testee data, a case report table quality controlling plan is generated and executed. A feedback is acquired and a quality controlling report is formed. Quality controlling is performed on the case report table by means of a clinical testing standard operation procedure. An online quality controlling operation to the clinical testing case report table is realized. Informationization degree in case report table quality controlling of clinical medicine tests is improved, and furthermore quality control efficiency of the clinical testing case report table is improved. The clinical testing case report table quality control system and the quality control method alleviate technical problems of low informationization degree and low quality control efficiency in case report table quality controlling of existing clinical medicine tests.

Description

technical field [0001] The present invention and the technical field of clinical trial data management, in particular, relate to a quality control system and a quality control method for a clinical trial case report form. Background technique [0002] Whether the drug clinical trials before the launch of new drugs can be carried out in strict accordance with the requirements of the Good Clinical Practice (GCP) is directly related to the safety and effectiveness of the drugs after they are launched. Therefore, clinical trial institutions need to establish a sound quality control standard system, which is one of the focus and important tasks of current drug clinical trial institutions. The Case Report Form (CRF) of clinical trials refers to a document designed according to the provisions of the trial protocol to record the data of each subject during the trial, since the case report form usually allows free text Entry, therefore, often results in erroneous records on drug cli...

AI Technical Summary

Problems solved by technology

[0004] In view of this, the object of the present invention is to provide a kind of clinical trial case report form quality control system and quality control method, to alleviate the informatization degree of the existing drug clinical trial case report form quality control, the quality control efficiency is low technical issues

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