论文部分内容阅读
(广东省药学会2016年4月21日印发)1目的为确保受试者权益,对临床试验过程中招募对象的选择、招募方式、招募材料、发布方式等予以明确;为伦理委员会审查,药物临床试验机构监管提供参考,使申办者、研究者在受试者招募过程中更加公平、合理、规范。2基本原则2.1所有患者/健康志愿者均有参加临床试验的机会;2.2选择招募对象时,应充分考虑其承担的研究风险和获益;2.3所有招募材料、招募发布方式等都需经过伦理委员会审查批准;
(Guangdong Pharmaceutical Association April 21, 2016 issued) 1 Purpose To ensure the rights and interests of subjects, the choice of clinical trials in the process of recruitment, recruitment methods, materials, methods of publication to be clear; for ethics committee review, the drug Clinical trial agencies to provide a reference for regulation, so that the sponsor, researchers in the process of recruitment of participants more fair, reasonable and standardized. 2 basic principles 2.1 all patients / healthy volunteers have the opportunity to participate in clinical trials; 2.2 choose the object of recruitment, should give full consideration to the research risks and benefits; 2.3 all recruitment materials, recruitment and distribution methods need to go through the Ethics Committee Review and approval