摘要
Ⅰ期临床试验必须遵循《赫尔辛基宣言》和《药物临床试验质量管理规范》(GCP),试验前充分评估受试者(预期和非预期的)风险,试验中严格遵守试验方案和标准操作规程(SOP),保障受试者的安全。
Each phase I clinical trail should abide by the Declaration of Helsinki and the Practice of Good Clinical Trial,the investigator must assess risk before the trial and comply with the protocol and SOPs throughout the trial,ensure that subjects who take part in a phase I clinical trail are adequately protected against any possible risks.
出处
《药学与临床研究》
2011年第6期561-564,共4页
Pharmaceutical and Clinical Research
