体外诊断试剂临床试验初始伦理审查申请表-首都医科大学附属北京佑.DOCVIP

首都医科大学附属北京佑安医院 人体研究保护项目 Beijing Youan Hospital,Capital Medical University Human Research Protection Program 附件Appendix26:EC-B-030-A03-V3.0 首都医科大学附属北京佑安医院 体外诊断试剂临床试验初始伦理审查申请表（第三版） APPLICATION TABLE FOR INITIAL ETHICAL REVIEW FOR IN VITRO DIAGNOSTIC REAGENTS (3rd) 2011.11.1制定 2013.01.22,2016.07.04修订 项目名称 Protocol name 申请审查形式 Review type □ 会议审查（需要签署知情同意书者）Convened EC Conference (informed consent form is signed) □快速审查（不需要签署知情同意书者）Expedited Review(informed consent form is not signed) 申办方/合同研究组织Sponsor/CRO 申办方/合同研究组织联系人 Contact person of Sponsor/CRO 主要研究者及其所在部门 PI and his/her department PI联系电话 PI tel. 研究摘要the abstract: 如果申请快速审查，请选择快审理由. If apply for expedited review ,please choose the reason: 快速审查条件Expedited Review Conditions 符合下列其中情况之一的任何一个研究项目都可采用初始快速审查Initial expedited review is conducted for any project meeting any of the following conditions： □ 对既往存档的数据、文件、资料、病理标本或诊断标本的收集或研究，并且这些资源是公共资源，或者信息是由研究者以无法联系受试者的方式记录的，可以快速审查。Any collection or research of data, documents, information, pathological samples or diagnosis samples previously archived can be review by Expedited review. These shall be are public resources, or the information is recorded by the investigator in a manner that the participants can’t be contacted. □ 已经证明为安全并按照被认可的技术参数进行操作的医疗器械的临床研究（注明：用来评估医疗器械的安全性和有效性的临床研究不适用于快速审查，包括任何带有附加指示的医疗器械的临床研究。）A clinical research of medical instrument that has been approved for sale, and is used according to its approved specifications (Note: a research that is to evaluate the safety and effectiveness of medical instrument is not applicable for expedited review, including any clinical research for additional indications of medical instrument). □ 不涉及个人隐私、不侵犯个人利益或不伤害受试者情感的临床研究. A research program that will not involve personal privacy, infringe personal interest, or harm the participant’s emotion. □ 从手指、足跟或耳朵采集少量的血样本（非频繁地）Collecting only a little blood sample, such as from the finger, heel, and ear (not frequently)； □ 采取人体标本无伤害的临床研究，例如采集体液、剪头发和剪指甲