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