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Objective:The paper aims to ensure the rational and legal utilization of genetic resources and maintain the national biosafety through the management of human genetic resources in clinical research carried out by medical institutions.Methods:Literature review and survey methods were adopted. Deming Circle, with focus on the four stages from planning, implementation, inspection, and countermeasures, was used to continuously improve the quality of human genetic resources management in the hospital.Results:The concept of hospital human genetic resources management was recognized and the management quality was significantly improved.Conclusions:The PDCA cycle management method is of positive significance to the management of human genetic resources in the clinical research of new drugs in medical institutions, and it is an effective way to improve the management level under current system.
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Electronic data capture(EDC) plays an important role in improving the quality of clinical research.The authors introduced the main functions of EDC and the use flow, then from its core function, analyzed the role of EDC in improving the quality of clinical research and scientific research management. Then they proposed the thinking of finding and solving problems from EDC " big data".Their efforts aim at enabling research administrators in extending clinical research management scope and management quality.
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A series of laws and regulations are the essential legal requirement in the field of clinical trial of medical device currently in China, especially the Provision for Clinical Trial of Medical Device. On the basis of current situation of medical device clinical trial, systemic analysis on the hot spot topics in the regulations was conducted to explore the way of improving the control system of clinical trial of medical device in China, which will provide the reference for medical device industry and the investigators of the clinical trial of medical device.
Subject(s)
China , Device ApprovalABSTRACT
Phase Ⅰ Clinical trial of new drugs is key for clinical drug development. In this article,we describe our experience and reflection on phase Ⅰ clinical trials of new drugs at the First Affiliated Hospital of Nanjing Medical University.
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This study retrospectively reviewed the experimental clinical programs at The First Affiliated Hospital of Nanjing Medical University. Experience was summarized, and methods for improving clinical pharmaceutical research were discussed including recruiting talent people, managing resources and trail results, and establishing international cooperations.
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This article presented the idea of implementation for the general hospital scientific research management information system.Based on the network and database,the scientific research management information system was constructed by analysis on the operation process of it;the information management of the scientific research management was implemented.This modern scientific research management information would improve the hospital scientific research management level.
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With the aid of scientific research management information system, we established an in-formation management for the scientific research funds. The structure,function and application of the system were introduced in this paper.
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OBJECTIVE:To provide reference for the standardization of the instructions of felodipine.METHODS:The instructions of felodipine in China were compared with the national regulation as well as foreign instructions of felodipine.The problems of Chinese instructions of felodipine were analyzed to put forward revision measures.RESULTS & CONCLUSIONS:The problems of Chinese instructions of felodipine are items shortage or missing,lacking of warnings for drug safety.It is suggested that related administration departments and enterprises should revise and improve the instructions of felodipine.
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OBJECTIVE: To probe into the regularity of drug consumption and to provide evidence for drug price control.METHODS: The actual purchase price,selling price,consumption sum and consumption quantity of all the drugs used in our hospital from 2003 to 2007 were taken as primary data to analyze the variation of drug price and consumption sum as well as the effect of the factor of drug price variation on drug consumption.RESULTS: The price fluctuation has big impact on the drug consumption,especially on the application structure of drugs characterized by the disappearance of the low price drugs from the market and substituting them with the "new drugs" which were prepared by altering dosage form,specification,package or brand name.CONCLUSION: It is advisable to adopt comprehensive measures rather than simple price reduction policy to control the artificial high price of drugs.