電子化審查流程對IRB影響之探討

The effect of electronic review process on Institutional Review Board

林柔君(Rou-Jyun Lin)

指導教授 ： 林文祥

義守大學/管理學院/管理碩博士班/碩士(2015年)

https://doi.org/10.6343/ISU.2015.00332

摘要

人體試驗審查委員會運作成功必須要有良好的制度，行政效率是審查過程中最常被詬病的地方，雖然批評並非客觀但卻成為各審查會重要改進之處，因此資訊化後，藉由電子化審查系統可節省審查時間及來回書信所花費的時間，並且改善缺失，增進委員會的審查效率，且利用電子化審查系統儲存各案件審查歷程及相關檔案資料，亦改善各審查會檔案存取問題，減少檔案遺失及損毀問題。
由本研究中提供之人體試驗審查委員會自紙本審查作業改為電子化審查作業後各項相關數據顯示，電子化審查作業不只為委員會節省下審查作業時間，亦為申請端、計畫主持人節省下回覆及修改計畫書後送審時間，此外亦可由電子化審查系統查詢案件進度與相關資訊，免除查詢等候時間及抱怨。紙本審查作業時的繁複流程及繁瑣文件資料，皆由電子化審查系統所替代，將提升整體審查作業之效率，此外，亦可利用電子化審查系統進行委員會內各項數據分析，如委員審查效率、行政審查效率，並可進一步分析出審查品質，藉此找出委員會審查問題，改善其問題或作業流程，進而提升委員會審查效率與品質，不只兼顧量與質，更可成為各大廠商與醫療機構人體試驗審查的依賴與指標。

關鍵字

人體試驗審查委員會 ； 電子化審查系統 ； 人體試驗

並列摘要

Institutional Review Board should be having a good system and the successful operation of the Review Committee, administrative efficiency is the most frequently criticized the review process. The criticism is not objective, but it becomes the important improvements for every IRB. After information technology upgrade, we can using the electronic review process to saving the message transfer of spend time, And improve deletion, enhance the efficiency of the Committee's review, use of the electronic review process can store each case history review and related archives. It will improve Each Committee's review about the access file problem, and reducing file loss and damage problems.
Institutional Review Board since this review paper to electronic operations of review work and the relevant data provided by the study shows the electronic review process not only for the Commission to review the job under review work to save time, also apply the applicant、program host friendly operation, and you can use electronic review process to predominate the program schedule, and return the message immediately, Institutional Review Board can exclusion query waiting time and complain. The review process paper complex and tedious job of documents, electronic review process rests alternative will enhance the efficiency of the overall review of the operations. In addition, the review can take advantage of the electronic review process of data analysis in the Commission, such as members of the review of the efficiency of administrative examination efficiency. And further analysis of the quality review, whereby the Committee reviewed to identify problems and improve their problem or processes, thereby enhancing the efficiency and quality of the review committee, taking into account not only the quantity and quality, but could become major manufacturers and medical institutions reviewed human trials dependence and indicators.

並列關鍵字

Institutional Review Board ； electronic review process ； human experimentation

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