【摘要】：我國藥物臨床試驗機構(gòu)經(jīng)過多年的發(fā)展,臨床試驗的試驗條件質(zhì)量有了一定的改善,但與發(fā)達國家相比,還存在著很多不足,應(yīng)用信息化管理有助于提高藥物臨床試驗質(zhì)量管理。文章對醫(yī)院II~IV期藥物臨床試驗項目管理系統(tǒng)的總體功能進行介紹,該系統(tǒng)從臨床試驗項目管理出發(fā),結(jié)合藥物臨床試驗運行特點及流程,實現(xiàn)臨床試驗項目及藥物全程管理,并與醫(yī)院信息管理系統(tǒng)、實驗室信息管理系統(tǒng)、醫(yī)學影像信息系統(tǒng)接口,構(gòu)建起機構(gòu)辦、藥物管理部門、檢驗檢查科室與研究者之間的公共信息平臺,實現(xiàn)了數(shù)據(jù)共享。
[Abstract]:After years of development, the quality of the clinical trial conditions has improved, but compared with the developed countries, there are still many shortcomings. The application of information management is helpful to improve the quality management of drug clinical trials. This paper introduces the overall function of the II~IV phase drug clinical trial project management system in hospital. The system starts from the clinical trial project management, combines the running characteristics and process of the drug clinical trial, and realizes the clinical trial project and the whole drug management. And the common information platform between hospital information management system, laboratory information management system and medical image information system is constructed, and the public information platform between the department of medical administration, the department of drug administration, the department of inspection and the researcher is constructed, and the data sharing is realized.
【作者單位】： 遼寧中醫(yī)藥大學附屬第二醫(yī)院;遼寧省中醫(yī)藥研究院;北京金靈蘭信息技術(shù)有限責任公司;
【基金】：國家“十二五”重大新藥創(chuàng)制項目(2012ZX09303-017) 國家臨床重點專科建設(shè)項目經(jīng)費資助 國家中醫(yī)藥管理局臨床中藥學重點學科 遼寧中醫(yī)藥大學杏林學者青藍工程
【分類號】：R95

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本文編號：2403199