1 实验准备阶段:Test preparation stage |
1、与伦理委员会(IEC)和研究机构沟通 Communicating with Ethics Committee (IEC) and research institutions |
2、协助研究者准备和递交伦理文件 Assisting researchers in preparing and submitting ethical approval documents |
3、中心启动准备 Initiation preparation of the center |
4、中心各部门人员沟通协调 Communication and cooperation of personnel from each department of the center |
2 实验执行阶段:Test performance stage |
1、研究中心文件管理 Document management of the research center |
2、研究药物管理 Drugs study management |
3、试验物资管理 Test material management |
4、原始资料整理 Original data compilation |
6、病历报告表填写 Filling in case report forms |
7、受试者访视管理 Visit and interview management of subjects |
8、配合监查、稽查和视查 Monitoring, auditing and inspection cooperation |
9、协助SAE的上报 Assisting in SAE reporting |
10、与伦理委员会(IEC)和研究机构沟通 Communicating with IEC and research institutions |
11、生物样本的管理 Management of biological samples |
3. 实验结束阶段: Test ending phase |
1、完成数据答疑 Fulfilling data question-answering |
2、试验药物的清点及回收 Inventory and recycle of investigational products |
3、物资的整理、清点回收 Clearing up, inventory and recycle of materials |
4、文件整理归档 File consolidation and archiving |
5、与伦理委员会(IEC)和研究机构沟通 Communicating with IEC and research institutions |