Medicine distribution recording system and method for clinical test

Abstract

The invention relates to a medicine distribution recording system and method for a clinical test. The medicine distribution recording system comprises a medicine distribution box, a controller and a management set unit, wherein the medicine box is provided with the controller; the controller is in a connection with the management set unit via a signal line or a wireless signal; the medicine distribution box comprises a plurality of cavities; the cavity is provided with a lid; an electronic lock is mounted between the lid and the cavities; an electronic lock controller, a microprocessor, an information storage unit, a wireless signal emission unit, an electronic map unit, a clock and an acousto-optic alarm device are disposed in the controller; the controller is equipped with a touch display screen, an electronic reader, a medicine information scanning reader, an image catching device and an audio recording device. The beneficial effects of the medicine distribution recording system and method are that careful medicine distribution and recovery records can be automatically recorded during the test; information of researchers or medicine dispensing persons can be recorded; testee body conditions and feelings after medicine taking can be directly recorded into the system by the researchers; and labor intensity of the researchers can be effectively reduced.

Description

technical field [0001] The invention relates to the field of medical devices, in particular to a system and method for recording medicine distribution for clinical trials. Background technique [0002] Drugs for clinical trials are the core of clinical trials. Drugs for clinical trials refer to test drugs, control drugs or placebos (GCP) used in clinical trials. Storage, distribution, use, and counting of test drugs during clinical trials Management is an important responsibility of researchers or research institutions, and plays a vital role in the reliability of test results. [0003] Investigators or pharmacies should also keep detailed records of the distribution and recovery of trial drugs: including the initials and codes of the subjects; the quantity, package number and date distributed to each patient; The number of empty packages and unused packages recovered from the test subjects; when the quantity of recycled packages is not enough, the reasons should also be re...

AI Technical Summary

Problems solved by technology

[0004] At present, the researcher’s test drug distribution and recovery records are still in the traditional mode. The researcher or pharmacy volunteers manually distribute them to the subjects according to the test design requirements, and the basic physical conditions of the test subjects, such as body temperature and skin color, are directly administered by the researcher. The observed changes and the feelings of the subjects after taking the medicine, etc., are recorded by the researchers or the medical staff of the pharmacy, and then input the handwritten records into the computer terminal, which is easy to cause inaccurate data, and the handwritten records are then compiled into a report , so that the researchers and related personnel have a great workload; because most of the clinical trials meet the requirements of blind and randomized trial design, and it is difficult to distinguish the experimental drug from the control drug or placebo in the experimental drug, the experimental drug is distributed In the process of giving subjects, it is easy to distribute mistakes

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