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各类别审查的送审文件清单Contents of Submitted Package
Templates
会议汇报ppt(初始审查-除美容保健及食品)
会议汇报ppt(初始审查-美容保健及食品)
职责授权书
研究方案
知情同意书(除美容保健及食品)Clinical informed consent form template
知情同意书(美容保健及食品)Clinical informed consent form template
研究者简历CV template for principal investigator
研究基地简介
Forms
伦理审查申请(初始审查)Application form of ethical review
复审修正明细及说明表
定期跟踪审查报告表Continuing review application form
修正案明细表Amendment request form
严重不良事件报告表Serious adverse event report form
违背偏离方案报告表Deviation/non-compliance/violation report form
暂停终止研究申请表Suspension & termination report form
暂停项目再启动申请表Resubmission application form
结题报告表Close-out report form
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18F, Building A, No. 380 Fenglin Road (Fenglin International Center)
021-33676001 021-33676247 (Office Tel)
021-33676540 (For Research Complaints)
seccr@scrcnet.org (Attachment less than 20MB)
scrciec2008@163.com (Attachment larger than 20MB)
Links
Shanghai Clinical Research Center
Shanghai Municipal Health Commission
National Health Commission of the People's Republic of China
Council for International Organizations of Medical Sciences (CIOMS)
European Network for Research Ethics and Integrity (ENERI)
Public Responsibility in Medicine and Research (PRIM&R)
National Institute of Health and Medical Research (INSERM)
HUST Center for Bioethics
中国人民大学生命伦理学研究所
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