| 摘要: |
| 依据GCP药物临床试验管理规范，分析我国药物临床试验伦理审查工作中存在的问题，从如何保障受试者知情同意、加强伦理委员伦理知识培训、全程伦理监督及引入伦理验收、加强监管力度和完善监督体制等4个方面对药物临床试验伦理审查工作提出针对性建议，以逐步完善我国药物临床试验伦理审查工作。 |
| 关键词: 药物临床试验 伦理审查 伦理委员会 |
| DOI： |
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| 基金项目: |
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| Problems and Countermeasures for the Ethical Review of Drug Clinical Trials |
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| Abstract: |
According to the GCP drug clinical trial management specification, analyzing the problems existing in ethical review of clinical trials of drugs, From how to guarantee the subjects’ informed consent, strengthen ethics committee of ethical knowledge training, introduce full ethical oversight and ethical acceptance, strengthen the supervision and perfect the supervision system four aspects put forward specific suggestions, to gradually improve ethical review of clinical trials of drugs. |
| Key words: drug clinical trial,ethical review,ethics committee |
