if the circumstances are serious, the drug manufacturing certificate, drug distribution certificate or the qualifications of the institution for drug clinical trial shall be annulled.
情节严重的,吊销《药品生产许可证》、《药品经营许可证》和药物临床试验机构的资格。
objective to analyze main causes of drop-out in drug clinical trial and explore the methods of management in reducing its rate.
目的分析药物临床试验中影响受试者脱落的主要因素,探讨降低受试者脱落率的管理方法。
as the human subject is taking a bigger risk in the drug clinical trial than in the ordinary medical treatment, the human subject's rights and interests must be fully protected.
实验性医疗行为较之于普通的医疗行为对患者来说具有更大的风险性,因此,必须对受试者的个人权益给予充分的保障。