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標準作業程序 第十一版
編號 標準作業程序 更新日期
標準作業程序架構與人體試驗審查委員會的組成 2020/07/01
1.1 名詞解釋與定義
Glossary and Definition
2020/07/01
1.2 制定標準作業程序與規範
2020/07/01
1.3 人體試驗審查委員會的組成
The Composition of Institutional Review Board
2020/07/01
1.4 隱私、保密和利益衝突之迴避管理
Privacy, Confidentiality and Conflict of Interest Management
2020/07/01
1.5 審查委員會委員及行政人員之教育訓練
Educational Training
2020/07/01
1.6 科學審查及其他專家受試者代表之諮詢
Scientific Review and Expert Consultant/Subjects(Groups) Representative Consultant
2020/07/01
1.7 研究倫理諮詢與輔導作業
Research Ethics Consultation and Counseling
2020/07/01
送審流程 (包括初審案、複審案、修正/變更案、持續審查與結案 2020/07/01
2.1 計畫書送審之管理
The management of Protocol Submission
2020/07/01
2.2 研究案初審重點及意見表的使用
The Initial Review Criteria of the Research and Review Opinion Form
2020/07/01
2.3 初審案 (一般審查、簡易審查)
Initial review ( Full Board Review, Expedited Review)
2020/07/01
2.4 社區研究、易受傷害及決定能力缺乏之受試者保護
Community Research, The Protection of Vulnerable Subjects and Subjects Lacking Decision Making Capability
2020/07/01
2.5 免審案之認定及其受試者保護
Exempted Review and exempt research are provided additional protections
2020/07/01
2.6 免除或改變知情同意
Waiver or alternation of informed consent
2020/07/01
2.7 複審案之審查
Resubmission
2020/07/01
2.8 追蹤(持續)審查程序
Continuing Review
2020/07/01
2.9 變更案(修正)
Amendment
2020/07/01
2.10 暫停/自行終止/撤案之處理準則
Suspension or Termination and Withdraw Protocol
2020/07/01
2.11 結案報告
Final Report
2020/07/01
2.12 緊急治療之審查
Emergency Use
2020/07/01
2.13 緊急會議
Emergency Meeting
2020/07/01
研究計畫案之安全性監測 2020/07/01
3.1 計畫風險和潛在利益評估
Assess the Risk And Potential Benefits Plan
2020/07/01
3.2 評估資料及安全性監測計畫之必要性
Evaluating of Data Safety Monitoring Plan
2020/07/01
3.3 嚴重不良事件及未預期問題之監測與通報
Monitor and Report Serious Adverse Event (SAE) and Unanticipated Problems (UP)
2020/07/01
3.4 不遵從(含試驗偏差及違規)事件通報及處置
Report and Management of Non-Compliance (deviation/violation) Events
2020/07/01
3.5 受試者投訴及申訴案件作業
Subjects complaints and appeals casework
2020/07/01
3.6 稽核和查核
Audit and Inspection
2020/07/01
3.7 實地訪查(或訪視監測)
Site audit visit
2020/07/01
3.8 人體試驗委員會暫停或終止研究計畫
IRB Suspendsor Terminates Research Program
2020/07/01
計畫主持人及研究團隊之倫理規範 2020/07/01
4.1 計畫主持人資格及研究團隊之倫理教育訓練
The qualification of the principal investigator and the ethical training of the research team
2020/07/01
4.2 研究團隊之利益衝突審議及處置
Management Conflict of Interest for Research Team
2020/07/01
多中心之研究計畫案之審查 2020/07/01
5.1 多中心研究計畫案之審查
Multi-Center Research
2020/07/01
5.2 非機構內研究計畫案之審查
Non-Institutional Research Protocol
2020/07/01
文件暨紀錄管理 2020/07/01
6.1 計劃檔案之管理及文件銷毀
Maintenance of the Study Files and Destroying Expired Documents Procedure
2020/07/01
6.2 會議程序與會議/通訊紀錄
IRB Meeting and Minutes and Communication records
2020/07/01
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