摘要
目的分析济南军区总医院(以下简称"我院")药物临床试验知情同意书的设计及签署情况。方法制订知情同意书设计及签署要素标准,调查我院58项药物临床试验知情同意书的设计及2042份知情同意书的签署中各要素的出现率,并对出现率低的要素进行深入分析。结果知情同意书的设计及签署基本符合《药物临床试验质量管理规范》的要求,但仍存在要素缺失及签署或修改不规范问题。国内项目的设计要素中,各缺失要素的出现率均低于国际多中心,出现率较低的有入选/排除标准(13.7%比71.4%)、试验保险及赔偿(7.8%比57.1%)、伦理委员会的联系人及联系方式(3.9%比85.7%)、知情同意书版本号及版本日期(41.2%比100.0%)。签署要素中以下容易被忽视:受试者联系方式、研究者联系方式未填写或填写固定电话、法定代理人代签时未注明受试者姓名及与受试者的关系,进一步分析发现,部分签署的缺失源于签字页项目设计不完整。结论针对发现问题提出对策,规范知情同意书的管理,促进我院药物临床试验的规范开展。
Objective To discuss the design and signature of informed consent form （ICF） from clinical trial drugs of Ji＇nan Military General Hospital （＂our hospital＂ for short）. Methods Items of design and signature from clinical trial drugs were made, the occurrence ratio of every item in 2042 ICF from 58 clinical trial drugs in our hospital were analyzed, and items with lower occurrence ratio were explored. Results Generally, the design and signature of ICF met the re- quirement of GCP. However, there were some defects of ICF and antonym of signature/revisions. In the domestic trail, the occurrence ratios of missing elements for design were lower than those in international trail, and the elements with low occurrence ratio were shown as follows： criteria of inclusion/exclusion （13.7% vs 71.4%）, pay and compensation （7.8% vs 57.1%）, the contact person and method of the Institutional Review Board （3.9% vs 85.7%）, ICF version num- bers and date （41.2% vs 100.0%）. The elements for signature frequently missed were the contact information of sub- jects, contact information of investigators which fill in landlines or nothing, the name of subject and the relationship with subject which legal representative did not write. The absence of signature elements was further analyzed and found that it was partly due to the design defects. Conclusion Studies the causes and puts forward countermeasures to stan- dardize informed consent, which promotes development of clinical trial in our hospital.
出处
《中国医药导报》
CAS
2014年第12期151-154,共4页
China Medical Herald
关键词
药物临床试验
知情同意书
设计
签署
Clinical trial drugs
Informed consent form （ICF）
Design
Signature
