
上海中医药大学附属曙光医院伦理委员会.doc
185页上海中医药大学附属曙光医院伦理委员会IRB of Shuguang Hospital affiliated with Shanghai University of TCM标准操作规程Standard Operating Procedure上海中医药大学附属曙光医院伦理委员会 2014年4月上海中医药大学附属曙光医院伦理委员会IRB of Shuguang Hospital affiliated with Shanghai University of TCM标准操作规程Standard Operating Procedure上海中医药大学附属曙光医院伦理委员会地址:上海市浦东新区张衡路528号邮编:201203:021-20256070邮箱:sgyyllwyh@版本号/日期:3.0,20140401目 录SOP01v3 伦理委员会标准操作规程的撰写、审查、颁布与修订(Writing, Reviewing, Distributing and Amending Standard Operating Procedures for Institutional Review Board)……………………………………………………………………………………… 1附件1伦理委员会标准操作规程列表(List of IRB SOP) ……………………………………… 5附件2 标准操作规程模板(Standard Operating Procedures Template) ………………… 7附件3 标准操作规程沿革表(Document History) …………………………………………… 8附件4 标准操作规程分发签名表(Log of SOP Recipients)………………………………… 8附件5 伦理委员会文件修订申请表(Request for Revising of a Document) …………… 9SOP02v3伦理委员会的组建(Establishing an Institutional Review Board) ………………… 10附件1 伦理委员会工作制度(IRB Working Policy) …………………………………………16附件2 伦理委员会委员职责(Functions of IRB Members) …………………………………17附件3 伦理委员会办公室职责(Functions of IRB Secretary and Staff) ………………18附件4 委员声明(IRB Member Announcement)…………………………………………………19附件5 委员与秘书通讯录(IRB Members List) ………………………………………………20SOP03v3 伦理审查的保密(Confidentiality Issues in Ethical Review) ………………………… 21附件1 保密协议(Confidentiality Agreement)………………………………………………23SOP04v3 利益冲突的管理(Management of Conflict of Interest)……………………………… 24附件1 利益冲突政策(Conflict of Interest Policy)………………………………………27附件2 利益冲突声明(Statement for Conflict of Interest) ……………………………29SOP05v3委员与秘书的培训(Training Personnel and IRB Members)…………………………… 30附件1培训计划(Training Plan) ………………………………………………………………33附件2培训资料目录(Contents of Training Material) ……………………………………34附件3培训会议签到表(Sign-in Sheet for Training Program)……………………………35SOP06v3独立顾问的选聘(Selection of Independent Consultants)………………………………36附件1独立顾问聘请书(Engagement Letter for Independent Consultant)………………39附件2顾问审查报告(Consultant Report Form)…………………………………………………40附件3独立顾问通讯录(Independent Consultant List) ………………………………………41SOP07v3 研究项目的预审/主审(Assessment of Study Protocol) ………………………………42SOP08v3会议审查与紧急会议审查(Full Board Meeting Review or Emergency Meeting Review) ………………………………………………………………………………47SOP09v3 加快审查(Expedited Review) …………………………………………………… 53SOP10v3 伦理审查的受理(Acceptions of Protocol Submission)…………………………… 56附件1送审文件清单(Contents of Submitted Package) ……………………………………59附件2送审材料登记表(Log of IRB Application Reception)………………………………61附件3伦理审查申请表(Application Form of Ethical Review)……………………………63SOP11v3 伦理审查的处理(Management of Protocol Submission) …………………………69SOP12v3 伦理审查的会议管理(Management of Convened Meeting) ……………………… 72附件1会议议程(Agenda for the Full Board Meeting) ……………………………………76附件2会议签到表(Sign-in Sheet of Full Board Meeting) ………………………………77附件3会议投票单(Voting of Full Board Meeting)…………………………………………78SOP13v3会议记录与审查决定(Minutes and Communication of Review Decision) ……… 79附件1会议记录(IRB Meeting Minutes)………………………………………………………… 83附件2伦理审查意见(Notification of IRB Review Decision)…………………………… 85附件3伦理审查批件(Approval Notice)………………………………………………………… 86SOP14v3 初始伦理审查(Initial Review)……………………………………………………… 88附件1初始审查工作表(Initial Review Worksheet)………………………………………… 92附件2 安慰剂对照审查参考(Guide to Placebo Justification)………………………… 95SOP15v3 按审查意见修正方案的再次审查(Review of Re-submitted Protocol)………… 97附件1 按审查意见修正方案的再次审查工作表(Review of Re-submitted Protocols Worksheet)……………………………………………………………………………… 101附件2 复审申请表(Resubmitted Review Form)……………………………………………… 102SOP16v3 修正方案审查(Review of Protocol Amendment)……………………………… 103附件1 修正方案审查工作表(Review of Amendment Protocol Worksheet)………………… 107附件2 修正方案伦理审查申请表(Amendment Request Form)……………………………… 108SOP17v3 (年度/定期)跟踪审查(Continuing Review)…………………………………… 109附件1 (年度/定期)跟踪审查工作表(Review of Continuing Review Worksheet)…… 113附件2 (年度/定期)跟踪审查报告(Continuing Review Application Form)………… 115SOP18v3 严重不良事件与非预期事件报告审查(Review of Serious Adverse Events and Unanticipated Problems)……………………………………………………………117附件1严重不良事件审查工作表 ……………………………………………………………… 121附件2严重不良事件报告(Serious Adverse Event Report Form)…………………………… 122SOP19v3 研究者不依从/违反研究方案的审查(Review of Protocol Deviation/Non-compliance/Violation)………………………………………………124附件1研究者不依从/违反方案审查工作表(Review of Protocol Deviation/Non-Compliance/Violation Worksheet)…………………………………128附件2研究者不依从/违反方案报告(Deviation/Non-Compliance/Violation Report)…… 128SOP20v3 提前终止研究报告审查(Review of Study Termination)……………………… 130附件1提前终止研究审查工作表(Review of Study Termination Worksheet)………… 134附件2提前终止研究报告(Study Termination Report)…………………………………… 135SOP21v3 处理受试者投诉(Response to Subject’s Complain)……………………………… 136附件1受试者投诉记录表(Complain Record Form)…………………………………………… 138SOP22v3 现场检查(Site Visits)……………………………………………………………… 139附件1现场检查清单(Checklist of a Site Visit)………………………………………… 142SOP23v3 结题报告审查(Review of Final Report)………………………………………… 143附件1结题报告审查工作表(Review of Final Report Worksheet)………。
