A SYSTEM AND A WAY TO AUTOMATICALLY MONITOR CLINICAL TRIALS - VIRTUAL MONITOR (VM) AND A WAY TO RECORD MEDICAL HISTORY

摘要

The subject-matter of the invention is a clinical trial automatic monitoring system comprising a programmable central unit consisting of a microprocessor and memory, at least one peripheral device, a server, a database, a network connecting the database to the server and the central unit, characterized in that the database is an EHR module comprising an interface and source data of one or more patients in the form of an electronic health record comprising at least personal data, medical history, medications taken; whereby the EHR module is networked to a VM which comprises a programmable central processing unit equipped with a microprocessor and memory and networked to a server; whereby the VM includes: (a) a CRF module to create clinical record files, equipped with MR form templates and containing a repository of clinical trial records, containing data entered during the clinical trial, in particular: the clinical trial setup, particulars of the staff members conducting the clinical trial, particulars of the patients participating in the clinical trial, observational data concerning one or more patients [enrolled] in the clinical trial, the CRF structures, multilingual MR templates, study results, and clinical analysis data; (b) A patient data access module connecting to the EHR module interface and importing data from the hospital system to the VM; (c) programmable instructions taking the form of an algorithm to generate description of illness based on the clinical trial configuration contained in the clinical trial protocol and an engine to generate MR text form templates with tree structures of fields, with each field containing a value needed to analyze the results of a given clinical trial, and each branch being a node that is assigned a specific text template; (d) a translation engine containing an algorithm and a medical repository of the medical terms and disease classification codes; (e) a user interface that presents on the display of the central unit and/or the display of a peripheral device the data pertinent to the entry generated in the CRF form; (f) a data processing module, comprising an algorithm serving the purpose of analyzing the consistency of the data from the CRF form with the data from the EHR module. Another subject-matter of the invention is a method to automatically monitor a clinical trial and a method to record the medical history.