臺灣博碩士論文加值系統

近年美國食品藥物管理局對各國藥廠發出警告，明白指出數據完整性的缺失逐年升高，在2017年比率已高達68%，這讓各國藥廠對數據完整性的問題必須更加重視。研究認為在全球化下，數據完整性的缺失會為藥廠帶來提升製藥產業結構的阻礙，同時也會增加藥廠進入跨國供應鏈的困難度，更重要的是，缺乏有效數據完整性管理的藥廠，會為其帶來負面信譽，降低藥廠的市場競爭力與市場佔有率。據此，探究藥廠對數據完整性規範的管理模式以及藥廠對專業人員的訓練係為本研究之目的，以釐清藥廠如何將專業人力訓練納入數據完整性的管理模式中，以及藥廠數據完整性的管理模式對專業人力訓練有什麼影響。研究發現，藥廠人員在數據完整性的訓練與落實程度已達約有八成的成效，但仍有約二成的員工尚未有完整的瞭解。有鑑於數據完整性對藥廠在產品品質維護上、與國際接軌上有非常重要的地位及效應，建立數據完整性不但是藥廠管理階層的任務，更是藥廠所有員工所必須擔負的責任，適當的數據完整性人員訓練是必須的。除此之外，最重要的要培育支持品質文化的人。因為藥品直接影響人類的生命和健康。

U.S. Food and Drug Administration recently warned that the deficiency of data integrity is a problem for drug manufacturers all around the world, the issue of data integrity should be the critical lesson for those who ignored the criteria. Based on globalization, the deficiency of data integrity would bring obstacles to the promotions of drug manufacturers and the structures of drug industry, and meanwhile the difficulties of entering into the cross-national supply chain would be escalated; furthermore, drug manufacturers without data integrity management would incur negative reputation as well as curtail market competitiveness and market shares. The purposes of study hence are to explore the management pattern of data integrity in drug manufacturers and the relevant training for employees, examining whether the employee training would be affected by the management of data integrity and scrutinizing how drug manufacturers put employee training into the proposals of data integrity management. The research reveals that the employee trainings of data integrity in drug manufacturers have been implemented at least 80% whereas 20% employees were still confused about the concept of data integrity. The research hence determines that data integrity not only is to maintain the quality of product but also is to construct consolidated status and efficacy on global market, and employees should burden it. Besides the necessity of employee training in data integrity, raising employees with quality culture is similarly significant.

目 錄
中文摘要 I
ABSTRACT II
致謝 III
目 錄 IV
圖目錄 VI
表目錄 VII
第一章 緒論 1
第一節 研究背景 1
第二節 研究動機 2
第三節 研究目的 4
第四節 研究問題 4
第五節 論文架構 4
第二章 文獻回顧 6
第一節 藥廠數據完整性規範的緣起 6
第二節 藥廠數據完整性實務 13
第三節 藥廠人員訓練 15
第三章 研究方法 28
第一節 研究架構 28
第二節 研究假設 28
第三節 研究對象 29
第四節 問卷設計 30
第五節 抽樣方法與樣本大小 34
第六節 資料分析 35
第四章 研究結果 37
第一節 描述性統計分析結果 37
第二節 交叉列表分析結果 42
第三節 推論性統計分析結果 46
第五章 討論 52
第一節 研究對象背景資料的影響 52
第二節 本研究範圍與限制 55
第六章 結論與建議 56
參考文獻 58
附錄一 專家效度委員一覽表 64
附錄二 IRB審核同意書 65
附錄三 正式問卷 66

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