药物临床试验质量控制的伦理研究∗

摘要

某医院以《药物临床试验质量管理规范》( GCP)为指导原则，在进行临床试验质量控制过程中与伦理委员会密切合作，采取了如下具体措施：从完善制度和标准操作规程，推行三级质控制度，强化GCP培训，临床试验药物及资料管理、临床试验数据资料的质量控制、伦理委员会审查及监督、全程质量控制(无缝对接)等方面紧密合作，从项目受理开始就实行无缝对接，对临床试验项目进行全程质量控制，这样能有效解决临床试验中存在的问题，提高临床试验质量。%Guided by good clinical practice ( GCP) , M hospital cooperated with the Ethics Committee in quali-ty management of clinical trials and took the specific measures including perfecting the institution and standard op-erating procedures, implementing three level quality control institution, strengthening the training of GCP, and closely cooperating with drug and data management of clinical trials, quality control in the clinical trial, ethical re-view and supervision, quality control in the whole process (seamless connection). Seamless connection from the beginning of project acceptance and quality control in the whole process of clinical trials can effectively solve the ex-isting problems in clinical trials and improve the quality of clinical trials.