Medicine clinical test supervision and administration system

Abstract

A medicine clinical test supervision and administration system comprises four parts which are respectively supervision and administration of organizations, supervision and administration of project procedures, supervision and administration of adverse events and supervision and administration of tested medicine, wherein the four parts participate in clinical test projects. Each supervision and administration part is composed of a presentation layer, a service layer and a data layer. Each presentation layer comprises a web server, a web component and a simple object access protocol (SOAP). Each service layer comprises a service component, a public service component, a service agency component, a domain object and the like. Each data layer is of a base layer data base structure. According to the medicine clinical test supervision and administration system, traditional supervision and administration information transfer modes of the four types of administration modes are changed to large-scale data base transfer modes so that supervision and administration of the medicine in individual combat and in a administrative region is changed to a large nationwide region, and therefore information sharing, cost saving and supervision and administration efficiency improving are achieved. Meanwhile, supervision and administration of the medicine is planned, each province office has specific supervision and administration tasks and frequency and focal points of project observation, and the problem of combination of daily supervision and register inspecting is solved.

Description

technical field [0001] The invention belongs to the field of drug supervision, and in particular relates to a drug clinical trial supervision and management system. Background technique [0002] In the process of clinical trials, many regulatory problems are faced, and drug safety is related to human life and health. At present, due to the absence of an accurate management system, the process of manual supervision and management of new drug clinical trials has the following problems: manual supervision is labor-intensive, high-cost, and low-efficiency; various records and document management organizations are messy, random, and incomplete ; All kinds of effectiveness and safety information generated during the multi-center trial cannot be shared, and it is difficult for each center to conduct a coordinated trial operation; the position of the investigator is too strong, and it is difficult for the trial institution and the sponsor to make a difference in the design and opera...

AI Technical Summary

Problems solved by technology

At present, due to the absence of an accurate management system, the process of manual supervision and management of new drug clinical trials has the following problems: manual supervision is labor-intensive, high-cost, and low-efficiency; various records and document management organizations are messy, random, and incomplete ; All kinds of effectiveness and safety information generated during the multi-center trial cannot be shared, and it is difficult for each center to conduct a coordinated trial operation; the position of the investigator is too strong, and it is difficult for the trial institution and the sponsor to make a difference in the design and operation of the trial. The center is in a dominant position and has a good quality control; the ethics committee is too superficial and formal, and lacks substantive management

[0003] Due to the lack of a unified management system, drug supervision is not planned, and government technical review is also facing difficulties: the quality of clinical trial data is not high, and there are even untrue and unobjective data;

[0004] The technical review department can only obtain the database and related summaries after the clinical trials are completed. At the same time, the review and approval of the national bureau is out of touch with the daily supervision of the provincial bureaus. The daily supervision conclusions of the provincial bureaus cannot be effectively used by the national bureau, so they can only use Time-consuming and labor-intensive means of registration verification to complete the verification of test project data; there are no relevant regulations on the submission of electronic data in clinical trials, so that the submitted data cannot be effectively used and work efficiency can be improved. Some good drugs cannot be marketed in time. The people are a great loss, and at the same time, it also makes the company bear too much pressure on the R&D capital turnover. A drug in the United States can make a profit of 1 million US dollars a day in the morning, and the company is very concerned about the review and approval speed of the national bureau; Understand the specific conditions of clinical trial institutions and projects, resulting in the failure to grasp the key points of the inspection even if on-site inspections are carried out

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