中华医学科研管理杂志
中華醫學科研管理雜誌
중화의학과연관리잡지
ZHONGHUA YIXUE KEYAN GUANLI ZAZHI CHINESE JOURNAL OF MEDICAL SCIENCE RESEARCH MANAGEMENT
2015年
4期
357-360,封4
,共5页
闫妍%时钢%高伟伟%门天男
閆妍%時鋼%高偉偉%門天男
염연%시강%고위위%문천남
药物临床试验机构%复核检查%规范化管理
藥物臨床試驗機構%複覈檢查%規範化管理
약물림상시험궤구%복핵검사%규범화관리
Drug clinical trial institutions%Review check%Standardized management
本文主要从药物临床试验机构复核检查实践出发,总结药物临床试验复核检查的重点内容,对机构办公室日常管理的现状及存在的问题进行分析,就机构办公室如何以复核检查标准为指导进行机构日常工作及临床试验项目等规范化管理进行了探讨,以期对其他药物临床试验机构复核检查及管理工作带来新的启示,为医院药物临床试验机构又好又快建设发展提供参考.
本文主要從藥物臨床試驗機構複覈檢查實踐齣髮,總結藥物臨床試驗複覈檢查的重點內容,對機構辦公室日常管理的現狀及存在的問題進行分析,就機構辦公室如何以複覈檢查標準為指導進行機構日常工作及臨床試驗項目等規範化管理進行瞭探討,以期對其他藥物臨床試驗機構複覈檢查及管理工作帶來新的啟示,為醫院藥物臨床試驗機構又好又快建設髮展提供參攷.
본문주요종약물림상시험궤구복핵검사실천출발,총결약물림상시험복핵검사적중점내용,대궤구판공실일상관리적현상급존재적문제진행분석,취궤구판공실여하이복핵검사표준위지도진행궤구일상공작급림상시험항목등규범화관리진행료탐토,이기대기타약물림상시험궤구복핵검사급관리공작대래신적계시,위의원약물림상시험궤구우호우쾌건설발전제공삼고.
This article from the clinical trials of the drug inspection agency review practice of view,summarize the key elements of drug clinical trials review examination,the status of agency offices of the daily management and analysis of the problems,the agency's Office to review how the inspection standards as a guide to clinical trial program files,personnel and other standardized management were discussed,with a view of other drugs in clinical trials and routine inspection agency review management to bring new inspiration,clinical trials of drugs for hospitals and fast construction and development agencies to provide a reference.
