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CLINICAL TRIAL ASSISTANCE APPARATUS, CLINICAL TRIAL ASSISTANCE METHOD AND CLINICAL TRIAL ASSISTANCE PROGRAM, AND PORTABLE TERMINAL DEVICE

机译:临床试验辅助装置,临床试验辅助方法和临床试验辅助程序以及便携式终端设备

摘要

PROBLEM TO BE SOLVED: To secure reliability of data on drug administration to each subject in a clinical trial, acquire biological values at points in time close to time of drug administration, and monitor condition of each subject after commercial launch of the drug.SOLUTION: A clinical trial assistance apparatus of the present invention includes; a reception processing unit which receives information identifying a drug taken by a subject, dosage of the drug administered, time administered, and image data containing a captured video image of the subject taking the drug from a portable terminal device operated by each subject; and a confirmation image generator unit which displays, on a terminal device of a checking party, the received information identifying the drug taken by the subject, dosage of the drug administered, and time administered as well as the received image data to allow the checking party to check if the administration of the drug is appropriate or not.
机译:要解决的问题:为了确保在临床试验中对每个受试者进行药物给药的数据的可靠性,在接近给药时间的时间点获取生物学值,并在药物商业投放后监控每个受试者的状况。本发明的临床试验辅助装置包括:接收处理单元,其从各对象操作的便携式终端装置接收用于识别由对象服用的药物,所服用的药物的剂量,所施用的时间,以及包含所摄取的对象的拍摄视频图像的图像数据的信息;确认图像生成器单元,其在检查方的终端设备上显示接收到的信息,该信息识别被检者服用的药物,所给药的药物的剂量和所分配的时间以及所接收的图像数据以允许检查方检查药物的使用是否合适。

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