本文選題：臨床試驗(yàn) + 監(jiān)查�。� 參考：《暨南大學(xué)》2014年碩士論文

【摘要】：藥物臨床試驗(yàn)作為新藥開發(fā)中至關(guān)重要的一步，對(duì)新藥研究開發(fā)及藥品上市具有重大的作用和意義，試驗(yàn)質(zhì)量的高低直接影響藥物能否通過(guò)審評(píng)并成功注冊(cè)。監(jiān)查作為監(jiān)督和檢查臨床試驗(yàn)過(guò)程的一個(gè)行為，是保證臨床試驗(yàn)質(zhì)量的重要環(huán)節(jié)，能夠保證試驗(yàn)按照試驗(yàn)方案、標(biāo)準(zhǔn)操作規(guī)程（standard operating procedure,SOP）和相關(guān)法規(guī)進(jìn)行，保障臨床試驗(yàn)中受試者的權(quán)益，保證試驗(yàn)數(shù)據(jù)準(zhǔn)確、完整，對(duì)臨床試驗(yàn)質(zhì)量控制具有重要影響。通過(guò)監(jiān)查，及時(shí)發(fā)現(xiàn)臨床試驗(yàn)實(shí)施過(guò)程中存在的問(wèn)題，從而加以糾正解決，不斷提高臨床試驗(yàn)的質(zhì)量。本文探討和分析監(jiān)查中發(fā)現(xiàn)的主要問(wèn)題及原因，并提出建議和對(duì)策，為指導(dǎo)臨床試驗(yàn)監(jiān)查工作，提高臨床試驗(yàn)質(zhì)量提供一定的參考。 本論文共抽取836份臨床試驗(yàn)項(xiàng)目監(jiān)查報(bào)告，以監(jiān)查報(bào)告所屬的臨床試驗(yàn)項(xiàng)目的藥物種類、試驗(yàn)分期、訪視時(shí)期作為分類標(biāo)準(zhǔn)，對(duì)監(jiān)查報(bào)告所反映的問(wèn)題進(jìn)行分析歸納，記錄于監(jiān)查報(bào)告記錄問(wèn)題提取表，分析并比較不同藥物種類、不同臨床試驗(yàn)分期的臨床試驗(yàn)在實(shí)施過(guò)程中出現(xiàn)問(wèn)題的異同，以及在不同的監(jiān)查訪視階段，監(jiān)查所發(fā)現(xiàn)的問(wèn)題的異同。通過(guò)基于頻數(shù)分析和卡方檢驗(yàn)的監(jiān)查報(bào)告記錄問(wèn)題的亞組研究，發(fā)現(xiàn)研究病歷/CRF填寫不及時(shí)/不完整、入組進(jìn)度緩慢是監(jiān)查過(guò)程中發(fā)現(xiàn)的最常見問(wèn)題，不同的臨床試驗(yàn)因?yàn)樵囼?yàn)特點(diǎn)不同，影響試驗(yàn)質(zhì)量的問(wèn)題發(fā)生情況有所差異。 在監(jiān)查過(guò)程中，我們應(yīng)當(dāng)根據(jù)不同的試驗(yàn)特點(diǎn)制定具體化的監(jiān)查計(jì)劃。利用電子數(shù)據(jù)采集系統(tǒng)，采取基于風(fēng)險(xiǎn)分析的集中化監(jiān)查將會(huì)是未來(lái)監(jiān)查模式的發(fā)展趨勢(shì)。除此之外，我們還可以通過(guò)建立監(jiān)查指導(dǎo)性文件、建立監(jiān)查員管理制度、大力推廣臨床研究協(xié)調(diào)員模式等方法提高監(jiān)查的效率和質(zhì)量，，從而提高臨床試驗(yàn)的質(zhì)量。
[Abstract]:As a crucial step in the development of new drugs, the clinical trial of drugs plays an important role and significance in the research and development of new drugs and the marketing of drugs. The quality of the trials directly affects whether the drugs can be evaluated and registered successfully.As an act of supervising and checking the clinical trial process, supervision and inspection is an important part of ensuring the quality of the clinical trial. It can ensure that the trial is carried out in accordance with the test plan, standard operating procedures, standard operating procedure and related regulations.Ensuring the rights and interests of the subjects in clinical trials and ensuring the accuracy and integrity of test data have an important impact on the quality control of clinical trials.The problems existing in the implementation of clinical trials can be found in time by monitoring, and the quality of clinical trials can be improved continuously.This paper discusses and analyzes the main problems and causes found in the monitoring and inspection, and puts forward some suggestions and countermeasures, which provides a certain reference for guiding the monitoring of clinical trials and improving the quality of clinical trials.In this paper, a total of 836 clinical trial project inspection reports were extracted, and the problems reflected in the monitoring report were analyzed and summarized with the drug types, trial stages and interview periods of the clinical trial items to which the monitoring reports belong as the classification criteria.Record the problem extraction table in the monitoring report, analyze and compare the similarities and differences between different drug types, clinical trials of different stages of clinical trials in the course of implementation, and at different monitoring and visiting stages,The similarities and differences of the problems found by the supervisor.Based on frequency analysis and chi-square test, the subgroup study of monitoring report record problem shows that the research case record / CRF filling is not timely / incomplete, and the slow progress of group entry is the most common problem found in the process of monitoring inspection.Problems affecting the quality of clinical trials vary according to the characteristics of the trials.In the process of monitoring, we should make specific inspection plan according to different experimental characteristics.Using electronic data acquisition system and adopting centralized monitoring based on risk analysis will be the development trend of monitoring mode in the future.In addition, we can improve the efficiency and quality of the inspection by establishing the supervisory guidance document, establishing the supervisor management system, and popularizing the model of clinical research coordinator, so as to improve the quality of clinical trials.
【學(xué)位授予單位】：暨南大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R95

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