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规章制度与法规指南
标准操作规程目录
| 序号 No. | 标准操作规程目录 Standard Operating Procedures（SOPs） |
| 1 | 标准操作规程的制定 Formulating Standard Operating Procedures for EC |
| 附件 1：标准操作规程模版 Standard Operating Procedures Template | |
| 附件2：厂翱笔分发签名表 Log of SOP Recipients | |
| 附件3：修订厂翱笔申请表 Request for Revision of an SOP | |
| 2 | 伦理审查申请指南的制定 Formulating Guidelines for Ethical Review Application |
| 附件 1：伦理审查申请受理及审查流程 Guideline about the Ethical Review Application | |
| 附件 2：送审文件清单 Contents of a Submitted Package(Checklist) | |
| 附件 3：伦理审查申请的各种表格及模板 Application Form & Template of Ethical Review Application | |
| 3 | 伦理委员会的组成 Constituting EC |
| 附件1：伦理委员会工作制度 EC Working Policy | |
| 附件2：伦理委员会委员职责 Functions of EC Members | |
| 附件3：伦理委员会办公室主任、秘书和工作人员职责 Functions of Office Director, Secretary, and Staff | |
| 附件4：伦理委员会成员简历模板 Member’s CV Template | |
| 附件5：伦理委员会组织构架图 Structural Drawing of EC | |
| 4 | 保密和利益冲突声明 Confidentiality Agreement / Statement for Conflict of Interest |
| 附件1：保密和利益冲突协议书 Confidentiality and Conflict of Interest Agreement | |
| 附件2：保密协议书 Confidentiality Agreement | |
| 附件3：保密协议书（视察/检查专家） Confidentiality Agreement（for inspector） | |
| 5 | 伦理委员会成员的培训 Training Personnel and EC Members |
| 附件1：培训记录表 Training Record Form | |
| 附件2：委员自我评估表 EC Members Self-evaluation Form | |
| 附件3：对委员的他评估表 Evaluation of EC Members Form | |
| 6 | 独立顾问的选择 Selection of Independent Consultants |
| 附件 1：专业服务协议书 Professional Services Agreement Form | |
| 附件 2：独立顾问咨询工作表 Independent Consultant Consultation Worksheet | |
| 7 | 研究方案送审的管理 Management of Protocol Submissions |
| 附件&苍产蝉辫;1：送审文件清单&苍产蝉辫; Contents of a Submitted Package | |
| 附件 2：知情同意书模板 ICF Template | |
| 附件3：主要研究者简历模板 Investigator CV Template | |
| 附件 4：伦理审查申请书（初始审查） Application Form of Ethical Review (Initial Review) | |
| 附件5：伦理审查项目受理登记表（初始审查） Checklist of Ethical Review Acceptance (Initial Review) | |
| 附件6：研究者汇报方案提纲 Protocol Present Outline | |
| 附件7：主要研究者利益冲突申明及研究材料诚信承诺书 Statement of Principal investigator | |
| 附件8：研究团队所有成员名单 List of All Members of the Research Team | |
| 附件9：研究成果的发布形式说明 Explanation of the Publication Form of Research Results | |
| 附件10：研究经费来源说明 Explanation of Funding Rources | |
| 8 | 研究方案的主审 Primary Review of Protocol |
| 附件 1：主审审评表（初始审查-注册） Assessment Form (Initial Review - Registered) | |
| 附件 2：主审审评表（初始审查-科研） Assessment Form (Initial Review - Research) | |
| 附件 3：主审审评表（初始审查-非医非药） Assessment Form (Initial Review - Non-medicine) | |
| 9 | 研究方案初始审查的会议审查 Review procedure of Initial review of board meeting |
| 附件 1：投票表 （初始审查） Voting Form (Initial Review) | |
| 附件 2：伦理审查意见模版 Notification Letter Template | |
| 附件 3：伦理审查批件模版 Approval Letter Template | |
| 10 | 医疗器械研究方案的审查 Review of Medical Device Studies |
| 附件&苍产蝉辫;1：医疗器械危险性分级标准 Significant Risk Device/ Non-significant Risk Device | |
| 11 | 快速审查 Expedited Review |
| 附件1：伦理审查项目受理登记表（非初审） Checklist of Ethical Review Acceptance (Non- Initial Review) | |
| 12 | 复审 Review of Re-submitted Protocols |
| 附件1：复审申请表 Re-submitted Protocols Review Application Form | |
| 附件2：复审审评表 Review of Re-submitted Protocols | |
| 13 | 研究方案的定期跟踪审查 Continuing Review of Study Protocol |
| 附件&苍产蝉辫;1：定期跟踪申请表 Continuing Review Application Form | |
| 附件2：定期跟踪审评表 Review Of Continuing Protocol | |
| 14 | 研究方案修正案的审查 Review of Protocol Amendments |
| 附件1：修正案审查申请表 Amendment Request Form | |
| 附件 2：修正案审评表 Review of Protocol Amendment | |
| 15 | 研究结题的审查 Review of End of Study |
| 附件&苍产蝉辫;1：研究结题报告表 Study Report Form | |
| 附件&苍产蝉辫;2：研究结题审评表 Review Form for Research Conclusion | |
| 附件&苍产蝉辫;3：项目归档表 Project Document Archiving Form | |
| 16 | 研究方案提前终止的审查 Review of Protocol Termination |
| 附件 1：提前终止研究报告表 Protocol Termination Request Form | |
| 附件 2：提前终止研究审评表 Review of Protocol Termination | |
| 17 | 不依从/违背方案的审查 Non-Compliance/Violation Intervention |
| 附件1：不依从/违背方案报告表 Non-compliance / Deviation Report Form | |
| 附件2：不依从/违背方案审评表 Review of Non-compliance / Deviation | |
| 18 | 严重不良事件/非预期不良事件的审查 Review of Serious Adverse Events & Unexpected Adverse Events |
| 附件1：严重不良事件/非预期不良事件报告表 Serious Adverse Event & Unexpected Adverse Event Report Form | |
| 附件2：医疗器械体外诊断试剂临床试验严重不良事件报告表 Serious Adverse Event Report Form for Clinical Trials of Medical Devices or In Vitro Diagnostic Reagents | |
| 附件3：严重不良事件/非预期不良事件审评表 Serious Adverse Event &Unexpected Adverse Event Review Form | |
| 19 | 受试者申诉的受理 Response to Participants' Requests |
| 附件1：受试者申诉记录表 Request Record Form of Participants | |
| 20 | 研究单位实地访查 Site Visit |
| 附件1：研究单位实地访查记录表 Site Visit Checklist | |
| 21 | 会议议程准备、会议内容及会议记录 Agenda Preparation, Meeting Procedures and Minutes |
| 附件1：会议议程模版 Meeting Agenda Template | |
| 附件2：会议签到表模板 Signature Template of Full Board Meeting | |
| 附件3：会议笔记模版 Meeting Notes Template | |
| 附件4：会议审查意见汇总（初始审查、重审） Review Report Summary of EC Meeting (Initial Review, Re-submitted Review) | |
| 附件5：会议审查意见汇总（复审） Review Report Summary of EC Meeting (Re- review) | |
| 附件6：会议审查意见汇总（定期跟踪审查） Review Report Summary of EC Meeting (Continuing Review) | |
| 附件7：会议审查意见汇总（修正案审查） Review Report Summary of EC Meeting (Review of Protocol Amendment) | |
| 附件8：会议审查意见汇总（不依从/违背方案审查） Review Report Summary of EC Meeting (Review of Non-compliance / Deviation) | |
| 附件9：会议审查意见汇总（厂础贰/厂鲍厂础搁审查） Review Report Summary of EC Meeting (Review of SAE/SUSAR) | |
| 附件10：会议审查意见汇总（提前终止研究审查） Review Report Summary of EC Meeting (Review of Early Terminated Research) | |
| 附件11：会议审查意见汇总（研究结题审查） Review Report Summary of EC Meeting (Review of Research Conclusion) | |
| 附件12：会议记录模版 Meeting Minutes Template | |
| 22 | 紧急会议 Emergency Meeting |
| 23 | 沟通记录 Communication Records |
| 附件1：沟通记录表 Communication Record Form | |
| 24 | 伦理委员会文档管理 Managing EC Files |
| 附件1: 伦理委员会审查项目数据库 Database of EC Review | |
| 25 | 文件保密 Confidentiality of EC’s Documents |
| 附件1：文件查阅/复印登记表 Log of Requested EC Documents | |
| 26 | 伦理委员会接受稽查和视察 Auditing and Inspection of the EC |
| 附件1：稽查/视察记录表 Log of Auditing or Inspection of the EC | |
| 27 | 研究项目文件第叁方保存交接 |
| 附件&苍产蝉辫;1：研究项目文件第叁方保存条形码、锁扣核对记录表 Verification Record Form for Barcodes and Locks of Documents Stored by Third Parties | |
| 附件&苍产蝉辫;2：研究项目第叁方保存明细 List of Documents Stored by Third Parties |
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