A file box for storing drug safety monitoring and audit files

Abstract

The invention relates to a file box, in particular to a file box for storing drug safety examining and checking files. The file box for storing the drug safety examining and checking files comprises a box body and an information indicating bag arranged on the lateral face of the box body. The file box for storing the drug safety examining and checking files is characterized in that a limit device and an information card are arranged in the information indicating bag. The information indicating bag is a bar-shaped bag, wherein the long side of the information indicating bag is sealed, and the short side of the information indicating bag is opened. The information card is provided with at least two information displaying areas, and the limit device is composed of an insertion board and a limit card arranged on the insertion board. The file box for storing the drug safety examining and checking files can record stored file information in detail and display the stored file information step by step, and the trinity monitoring data management on drug safety can be conveniently achieved.

Description

technical field [0001] The invention relates to a file box, in particular to a file box for storing drug safety monitoring and audit files. Background technique [0002] At present, the hospital's clinical monitoring of drug safety needs to record the patients who have adverse reactions, the type of adverse reactions, the time of occurrence, severity, and remission, etc., and there are many volunteers involved in clinical trials, especially for the detection of traditional Chinese medicine preparations. The number of people in the experiment and the adverse reaction observation items are often more than those observed by western medicine, so a large amount of data will be generated. And in order to ensure the accuracy of the test results, it is necessary to ensure the accuracy of the data. [0003] At present, the testing data of drugs in hospitals is often collected by clinical nurses, clinicians or clinical pharmacists, and then filled in the CRF form and then archived. W...

AI Technical Summary

Problems solved by technology

[0003] At present, the testing data of drugs in hospitals is often collected by clinical nurses, clinicians or clinical pharmacists, and then filled in the CRF form for archiving and storage. Without the monitoring and auditing of drug reactions by the other two, the accuracy and quality of data collection cannot be guaranteed. integrity

[0004] Moreover, due to the hugeness of the detection data, the existing file boxes are usually only equipped with ordinary information columns on the side, and the information of the stored data cannot be organized in a hierarchical and orderly manner, which increases the difficulty of managing the monitoring data.

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