本文選題：臨床試驗(yàn)主文檔　切入點(diǎn)：數(shù)據(jù)管理　出處：《藥學(xué)學(xué)報(bào)》2015年11期

【摘要】：臨床試驗(yàn)質(zhì)量管理規(guī)范(GCP)規(guī)定所有臨床試驗(yàn)的信息應(yīng)該被記錄、處理和保存并能被準(zhǔn)確地報(bào)告、解釋和核查。臨床試驗(yàn)主文檔(trial master file,TMF)是臨床試驗(yàn)中產(chǎn)生的所有相關(guān)的紙質(zhì)或電子文檔。作為一種回顧性分析,一個(gè)完整的試驗(yàn)主文檔應(yīng)可以完整地再現(xiàn)臨床試驗(yàn)的過程。臨床數(shù)據(jù)管理文檔是試驗(yàn)主文檔的一部分,其準(zhǔn)確完整性是反映數(shù)據(jù)真實(shí)可靠性的重要證據(jù)之一。本文通過了解臨床試驗(yàn)不同階段的數(shù)據(jù)管理流程而幫助了解每個(gè)階段需要哪些文檔,并理解數(shù)據(jù)管理文檔對(duì)數(shù)據(jù)真實(shí)可靠性的重要性。同時(shí)闡述了如何進(jìn)行良好的臨床數(shù)據(jù)文檔管理,只有在切實(shí)地理解臨床數(shù)據(jù)管理的全過程的基礎(chǔ)上,進(jìn)行嚴(yán)格而有效的文檔管理和定期的質(zhì)量控制才是高質(zhì)量數(shù)據(jù)管理文檔的保證。
[Abstract]:The Clinical trial quality Management Code (GCPs) states that all clinical trial information should be recorded, processed and preserved and can be accurately reported. Interpretation and verification. The clinical trial master document trial master fileTMFs are all relevant paper or electronic documents produced in clinical trials. As a retrospective analysis, A complete trial master document should be able to reproduce the clinical trial process completely. The clinical data management document is part of the trial master document. Accuracy and completeness is one of the important evidence to reflect the reliability of the data. This paper helps to understand what documents are required for each phase by understanding the data management processes at different stages of a clinical trial. The importance of data management documents to the reliability of data is understood. At the same time, how to manage good clinical data documents is expounded. Only on the basis of understanding the whole process of clinical data management, Strict and effective document management and regular quality control are the guarantee of high quality data management documents.
【作者單位】： 美達(dá)臨床數(shù)據(jù)技術(shù)有限公司;杭州泰格醫(yī)藥科技有限公司;
【分類號(hào)】：R95

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