课题基金 / 基金详情

Protocol Application Tracking System

Protocol Application Tracking System
协议应用跟踪系统
批准号:
6773082
负责人:
DOMINICK PURPURA
金额:
$30.0万
依托单位国家:
美国
项目类别:
财政年份:
2002
资助国家:
美国
项目状态:
已结题
起止时间:
2002-09-01 至 2004-08-31

项目摘要

项目成果

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中文摘要
翻译
保护人类受试者是所有临床研究者和机构的首要任务。阿尔伯特·爱因斯坦医学院、蒙蒂菲奥里医学中心、费尔考夫心理学研究生院和维尔茨韦勒社会工作学院坚持对人类受试者进行安全和合乎道德的治疗的坚定承诺。两个机构审查委员会(irb)位于阿尔伯特·爱因斯坦医学院(爱因斯坦)和蒙蒂菲奥里医学中心(MMC)监督这四个机构的所有人体研究协议。irb在联邦批准的合作协议的支持下运作,该协议确保机构监督和遵守联邦法规。当一个IRB充当主要审稿人时,另一个IRB通过Ad Hoc机制保持通知。两个审计委员会定期召开联席会议委员会会议,审查政策、程序和相互关注的问题。我们的目标是扩大
英文摘要
The protection of human subjects is of high priority to all clinical investigators and institutions. The Albert Einstein College of Medicine, Montefiore Medical Center, Ferkauf Graduate School of Psychology, and Wurzweiler School of Social Work maintain a strong commitment to the safe and ethical treatment of human subjects. Two Institutional Review Boards (IRBs) located at the Albert Einstein College of Medicine (Einstein) and Montefiore Medical Center (MMC) oversee all of the human research protocols at these four institutions. The IRBs function under the auspices of a federally-approved Cooperative Agreement which ensures institutional oversight and adherence to federal regulations. While one IRB serves as the Primary Reviewer, the other is kept informed via an Ad Hoc mechanism. The two IRBs meet regularly in a Joint Conference Committee to review policies, procedures and mutual concerns. Our aim is to extend the implementation of the Einstein/MMC web-based Protocol Application and Tracking System (PATS) to the Ferkauf Graduate School of Psychology and Wurzweiler School of Social Work. The addition of PATS to Ferkauf and Wurzweiler will enhance the monitoring and coordination of behavioral and social research, reduce submission errors, track all required paperwork (including amendments, progress reports, adverse events, etc), and enhance the quality assurance program. In addition, we propose to customize the human subjects educational component at Ferkauf and Wurzweiler by dealing specifically with issues related to behavioral and social research. Tailored seminars will be offered on all campuses to make it easier for faculty and students to attend. These customizations will require infrastructure, technology and educational materials development. Resources are requested for the continuing development and alterations to the multiplatform web-based application as well as the educational component. This will ensure high quality monitoring and coordination of the behavioral and social research protocols conducted at each institution.
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EXTRAMURAL RES FACILITIES: TUBERCULOSIS AND GENETICS
EXTRAMURAL RES FACILITIES: BIODEFENSE: MTB, B ANTHRACIS
EXTRA RES FACIL: FUNGI, GENOMICS, PROTEOMICS, DRUG DISCOVERY, BIOINFORMATICS
EXTRAMURAL RES FACILITIES: CRYPTOCOCCAL NEOFORMANS
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