A: 试验准备及进行阶段 Study Start—up and On going
1.中心访视登记表 Site Visit Log
2.SFDA批件 Health Authority Approval
3.申办方三证及申办方委托证明 Certificates of sponsor & entrustment
4.研究者手册及更新 Investigator’s Brochure and updates
5.试验方案及方案修正版 Protocol /Protocol modification （Approved）
6.病例报告表及更新件（样表) Blank CRF and updates （Approved)
7.知情同意书及更新件(样本） Informed Connt Form and updates
8.受试者日记/原始病历 Subject Diary/Source Document (Sample）
9.药检报告及新的药检报告 Certificate of analysis of products & updates
10.试验用药品说明书 Specification of Investigational Product
11.伦理递交信/伦理批件及组成名单及更新
IEC submitted letter /IEC Approval Form & member list, and updates
12.研究中心合同 Signed agreement with Sites （contract）
13.研究者总数及研究者简历/资质证书及更新
No. of investigators & CV of investigator（s） / Certificate & updates
14.试验启动会（日程、出席签到、会议记录、启动访视表)
Initiation Meeting （agenda, attendance record, minutes, initiation visit）
15.保险责任声明 Insurance Statement
16.付款记录 Clinical trial expen report
17.任务授权表及更新 Study Authorization Form & updates
18.方案认可签署页及更新件 Protocol signature page ＆ updates
19.实验室正常值范围及更新件 Lab Normal Values and updates
20.实验室资质证书 Lab Validation / other certification
21.从CRO或申办方到研究中心药品运送记录
Shipping records for products supply from CRO/sponsor to Site
22.研究者接收药品签收 Confirmation of receipt of products by investigator
23.试验相关用品供应表 Study Related Material Supply Form
24.受试者筛选表/筛选失败表 Subject Screening Log/ Screening Failure Log
25.受试者入组登记表 Subject Enrollment and Identification Code List
26.受试者提前退出表 Subject Withdraw Log
27.SAE跟踪记录表 SAE Tracking Form
28.研究者致申办者的严重不良事件报告及上报EC/SFDA
SAE and EC /SFDA report
29.向EC/SFDA上报非预期的严重不良事件和其他药物安全信息
Notification to EC/SFDA of unexpected SAE and other safety information
30.试验药品发药登记表 Drug Dispensing Log
31.试验药品库存表 Drug Inventory Log
32.温度记录表 Temperature Log
33.原始资料 Source document
34.中期或年度报告 Reports to Authority/IEC （interim or annual）
B: 试验结束阶段 Study Clo Down
1.药物回收记录 Drug Return Form
2.药物销毁记录及证明 Drug Destruction Document
3.受试者入组编码（完整）(即受试者入选情况一览表）
Subject Identification Code List Final / Completed
4.试验总结报告 Clinical Study Report
5.研究分中心报告 Site Study Report
6.致伦理信告试验结束 Notification of Study Clo-down to EC
7.致研究者感谢信 Thanks letter to the investigator
