| 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 |
2024/4/30 |
| 1.1 |
制定標準作業程序撰寫、頒布及修訂
Glossary and Definition |
2024/4/30 |
| 1.2 |
人體試驗審查委員會的組成
Draw Standard Operating Procedure and Guideline |
2024/4/30 |
| 1.3 |
隱私、保密和利益衝突與迴避管理
The Composition of Institutional Review Board |
2024/4/30 |
| 1.4 |
委員及行政人員教育訓練
Privacy, Confidentiality and Conflict of Interest Management |
2024/4/30 |
| 1.5 |
科學審查及其他專家諮詢
Educational Training |
2024/4/30 |
| 1.6 |
研究倫理諮詢與輔導作業
Scientific Review and Expert Consultant/Subjects(Groups) Representative Consultant |
2024/4/30 |
| 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 |
2024/4/30 |
| 2.1 |
計畫書送審之管理
The management of Protocol Submission |
2024/4/30 |
| 2.2 |
研究案初審審查重點及意見表的使用
The Initial Review Criteria of the Research and Review Opinion Form |
2024/4/30 |
| 2.3 |
一般審查及簡易審查作業程序
Initial review ( Full Board Review, Expedited Review) |
2024/4/30 |
| 2.4 |
易受傷害族群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 |
2024/4/30 |
| 2.5 |
免審案之認定及受試者保護
Exempted Review and exempt research are provided additional protections |
2024/4/30 |
| 2.6 |
免除或改變知情同意
Waiver or alternation of informed consent |
2024/4/30 |
| 2.7 |
複審案審查作業程序
Resubmission |
2024/4/30 |
| 2.8 |
持續審查作業程序
Continuing Review |
2024/4/30 |
| 2.9 |
變更案作業程序
Amendment |
2024/4/30 |
| 2.10 |
中止終止與撤案之處理準則
Disposal Guidelines for Suspension/ Termination and Withdrawal in Advance |
2024/4/30 |
| 2.11 |
結案報告之處理準則
Final Report |
2024/4/30 |
| 2.12 |
恩慈療法專案進口健保事前審查專案給付審查作業程序 |
2024/4/30 |
| 2.13 |
緊急會議
Emergency Meeting |
2024/4/30 |
| 2.14 |
新醫療技術審查原則及作業程序 |
2024/4/30 |
| 參 |
研究計畫案之安全性監測 |
2024/4/30 |
| 3.1 |
計畫風險和潛在利益評估
Assess the Risk And Potential Benefits Plan |
2024/4/30 |
| 3.2 |
評估資料及安全性監測計畫之必要性
Evaluating of Data Safety Monitoring Plan |
2024/4/30 |
| 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) |
2024/4/30 |
| 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 |
2024/4/30 |
| 3.5 |
受試者投訴及申訴案件
Subjects complaints and appeals casework |
2024/4/30 |
| 3.6 |
稽核和查核
Audit and Inspection |
2024/4/30 |
| 3.7 |
實地訪查（或訪視監測）
Site audit visit |
2024/4/30 |
| 肆 |
計畫主持人及研究團隊之倫理規範 |
2024/4/30 |
| 4.1 |
計畫主持人資格及研究團隊之相關倫理教育訓練
The qualification of the principal investigator and the ethical training of the research team |
2024/4/30 |
| 4.2 |
研究團隊之利益衝突處理
Management Conflict of Interest for Research Team |
2024/4/30 |
| 伍 |
多中心之研究計畫案之審查 |
2024/4/30 |
| 5.1 |
多中心之研究計畫審查
Multi-Center Research |
2024/4/30 |
| 5.2 |
非機構內之研究計畫審查
Non-Institutional Research Protocol |
2024/4/30 |
| 陸 |
文件暨紀錄管理 |
2024/4/30 |
| 6.1 |
計劃檔案之管理及文件銷毀
Maintenance of the Study Files and Destroying Expired Documents Procedure |
2024/4/30 |
| 6.2 |
會議程序與紀錄及通訊記錄
IRB Meeting and Minutes and Communication records |
2024/4/30 |