| 編號 |
標準作業程序 |
更新日期 |
| 壹 |
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 |
| 貳 |
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 |
| 參 |
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 |
| 肆 |
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 |
| 伍 |
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 |
| 陸 |
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 |