Handheld data acquisition device for clinical test

Abstract

The invention discloses a handheld data acquisition device for a clinical test. The handheld data acquisition device comprises a biological recognition identity unit, a biological recognition identity information pre-storing unit, a unit for pre-storing examination item information in a laboratory examination report sheet, a clinical test hospital data read-in unit, an image pickup unit, an image-text recognition unit, a data storage unit, a new data detection unit and a wireless network module. The handheld data acquisition device can read data on the laboratory examination result report sheet in the clinical test and send the data to a designated data server through a wireless network, such as the data server of a clinical test data management center, has the advantages of being quick and accurate and overcomes the shortcomings of large working amount and cross data checking brought by manual entering of laboratory examination results in the clinical test.

Description

technical field [0001] The invention relates to the field of data acquisition devices, in particular to a hand-held data acquisition device for clinical trials. Background technique [0002] It is a long process from the beginning of basic research to the approval and production of new drugs. Foreign new drugs generally take more than 10 years, and the average development cost of each new drug is about 300-500 million US dollars; more than 70% of the time and cost It is used in clinical research, so clinical trials are an important link that restricts time and cost in the research and development of new drugs. Clinical trial: refers to any systematic study of drugs in humans (subjects: patients or healthy volunteers) to confirm or reveal the effects, adverse reactions and / or absorption, distribution, metabolism and excretion of experimental drugs, The purpose is to determine the efficacy and safety of the test drug. [0003] The processing of laboratory test results in exi...

AI Technical Summary

Problems solved by technology

Among them, the first mode will be gradually eliminated due to the need to transport the case report form from the research hospital to the data processing center, which is time-consuming, has poor real-time data, and is not conducive to the development of cross-regional and multinational clinical trials; Although the two modes solve the real-time nature of data, manual input is still required, and the workload has not been reduced

Both acquisition modes are cumbersome and error-prone

[0008] In recent years, the application of image recognition technology has become more and more widespread. Image recognition has the disadvantage of low accuracy of text recognition, and the corresponding regulations of clinical trials require that the accuracy of data must reach 100%. If it is directly applied to clinical trials, due to the accuracy of recognition The rate is low and it takes a lot of time to make corrections, and the actual efficiency is not high. Therefore, no one has applied graphic recognition technology to clinical trial data management at present.

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