临床试验职责分配表/ Responsibility Assignment of Clinical Trials
职责/ Responsibilities | 分配/ Assignment | |||
客户 Party A | 医院 Site | 公司 Party B | ||
资料提供 Data Preparation | 上市证明等 Marketing File etc. | ▲ | △ | |
样机，样品及说明书等 Sample, IFU and etc. | ▲ | △ | ||
产品技术要求和全性能检测报告 PTR & testing report | ▲ | △ | ||
试验启动 Trial Commence | 临床试验基地选择，确定伦理事宜 Site Selection, EC Issues | △ | ▲ | |
临床试验方案的起草，讨论和确认 Draft, discuss and confirm the trial protocol | △ | ▲ | ||
临床试验启动会议 Kicking off meeting | △ | ▲ | ||
试验过程 Trial Process | 伦理委员会会议 EC Review | △ | ▲ | ▲ |
遗传办审批（如需） HGRAC Approval (if necessary) | △ | ▲ | ||
省局备案 Local MPA Filing | △ | ▲ | ||
试验样品的提供和确认 Sample Supply and Confirmation | ▲ | △ | ||
临床试验过程跟踪，方案的修改和调整 Trial Tracking, Protocol Modification & Adjustment | △ | ▲ | ▲ | |
临床试验质控与监查 QA and CRA | ▲ | ▲ | ||
试验数据的收集和整理 Data Collection and Collation | △ | ▲ | ▲ | |
数据处理和统计学分析 Data Processing & Statistical Analysis | △ | ▲ | ▲ | |
临床试验报告起草，确认，盖章和交付 Trial Report Drafting & Confirmation & Signature and Delivery | △ | ▲ | ▲ | |
备注 Notes | 1.“▲”——主导方/ Leading Party，“△”——协助方/ Assisting Party 2.具体工作安排以项目启动后双方协商为准/ The specific work arrangement shall be based on the consultation between the two parties after project initiation. | |||
Procedures of animal test
1.Choose a GCP test base with scientific research capabilities;
2.Develop a trial protocol for animal test;
3.Analysis and summary of test conclusions;
4.The summary of the test report is completed.
1. Clinical trial base selection & determination of clinical research;
2. Drafting, discussion and validation of clinical trial protocols;
3. Clinical trial initiation meeting;
4. Preparation of clinical data and explanation of test items;
5. Provision and confirmation of test samples;
6. Tracking of clinical trial procedures, modification and adjustment of trial protocols;
7. Collection and collation of test data;
8. Data processing and statistical analysis;
9. Clinical trial report drafting, validation, stamping and delivery.
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