System and method for generating clinical test electronic case report form

Abstract

The invention discloses a system and a method for generating a clinical test electronic case report form, and relates to an electronic case report form. A data acquisition module is used for acquiringclinical data and medical record data of a subject; a generation module is used for generating a clinical test electronic case report template which comprises a plurality of test items, each test item comprises a plurality of test elements, and a logic verification specification is preset for each test element; the import module is used for importing the clinical data and the medical record datainto each test element to generate an initial electronic medical record report form; the verification module is used for respectively matching the clinical data and the medical record data with logicverification specifications corresponding to the corresponding test elements, and generating and outputting alarm information when the clinical data and the medical record data do not accord with thelogic verification specifications; and the correction module is used for performing correction according to the alarm information to obtain a clinical test electronic medical record report table. Thesystem and the method have the following beneficial effects: automatic acquisition and inspection management of all data in the clinical test electronic case report form are realized.

Description

technical field [0001] The invention relates to an electronic case report form, in particular to a system and method for generating an electronic case report form for clinical trials. Background technique [0002] Clinical trials refer to any systematic study of drugs in humans to confirm or reveal the effects, adverse reactions and / or absorption, distribution, metabolism and excretion of test drugs, with the purpose of determining the efficacy and safety of test drugs. Clinical trials are generally divided into multi-phase trials, and the time span generally takes several years. The electronic case report form refers to an electronic file designed according to the provisions of the trial protocol, which is used to record the data of each subject during the trial. Among them, the standardized data collection and management of clinical trials is an important content in clinical research, and the quality of data is directly related to whether the safety and effectiveness of d...

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Problems solved by technology

[0003]The hospital has always been "patient-centered" as its principle, with the goal of "improving the quality of clinical trials and ensuring the safety of subjects", but the clinical trial cycle is long and the trial The process is complex and is a weak link in hospital management, and the traditional paper-based case report form (Case Report Form) requires a large number of personnel to collect and enter data, and there are more medical risks for the subjects , in order to ensure the safety of subjects, it needs to spend huge manpower and material resources on supervision and verification, but this method still lacks stricter management of clinical trial data

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