Clinical data standardization system and standardized data acquisition method

Abstract

The invention discloses a clinical data standardization system and a standardized data acquisition method. The system comprises a standardized data acquisition platform, a data inspection platform anda business system; the standardized data acquisition platform comprises an in-row standard configuration module, a follow-up visit plan configuration module, a scientific research metadata managementmodule, a scientific research case management module, a standardized maintenance module, an acquisition module, a service interface module and an eCRF management module. The data acquisition method comprises the following steps: enabling a doctor workstation to generate a service application form and service system data based on the content to be followed by a patient, performing data cleaning and conversion through a standardization pool, and automatically filling a disease library of the eCRF management module after standardization processing. Under the condition of fully fusing standard codes and service interfaces in the biomedical field at home and abroad, the background annotation is carried out on differentiated standards, the differentiated standards are integrated into a dictionary, different standard backgrounds are compiled, and then correction is carried out through an algorithm, so that errors are reduced, and the bias rate is reduced.

Description

technical field [0001] The invention belongs to the technical field of clinical data standardization, and relates to a clinical data standardization system and a standardized data collection method. Background technique [0002] In recent years, with the development of information technology, electronic data acquisition technology has been increasingly adopted in clinical trials. Electronic data capture (Electronic Data Capture, EDC) is a computer network-based technology for clinical trial data collection, through the organic combination of software, hardware, standard operating procedures and staffing, it is directly collected and transmitted in electronic form clinical data. At present, mobile electronic devices such as tablet computers, smart phones, scanners, etc. have already met the conditions as EDC terminals. Management systems are integrated into one; at the same time, internationally recognized data standards (such as CDISC) are also being applied in EDC. Many ...

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Problems solved by technology

[0003] In the medical information system, because medical terms cover a large number of word segmentation databases with complex word formation in the medical field, in the absence of information planning, different clinical information standards will hinder the interaction of clinical data, and independent clinical information systems The names and data formats of the generated data are different, and it is difficult to further use clinical data to guide current medical management and clinical scientific research. The standardization of clinical data can solve this problem and provide a solution for clinical data collection

[0004] The existing clinical information standard system is complex and mixed, clinical data standardization tools are poor, and clinical data standardization work is difficult to implement. Inconsistent calibers lead to overreading of standards, which eventually leads to large biases in clinical data

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