Protocol Application and Tracking System

协议申请和跟踪系统

• 批准号: 6591467
• 负责人: DOMINICK PURPURA
• 金额: $ 30万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-09-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591467
• 关键词: Internet; clinical research; computer data analysis; data management; ethics; health science research support; human rights; information systems; informed consent; method development; training

The assurance of human subject safety is of paramount importance in the conduct of clinical research. The Albert Einstein College of Medicine and Montefiore Medical Center have had a long-standing commitment to ensuring a safe and ethical environment for human subjects and patients who participate in clinical research. Human subject research protocols that are to be conducted at both Einstein and Montefiore are governed by a federally-approved Cooperative Agreement. Under the Cooperative Agreement, one of the two institutions assumes responsibility as the Primary Review institution. The Cooperative Agreement arrangement provides institutional oversight in compliance with all federal guidelines, avoids potential problems associated with a duplication of effort on the part of investigators, and serves to keep both institutions fully informed of the status of each protocol. The appointed Primary Review institution accepts responsibility for the oversight of its protocols and keeps the other institution informed via an Ad Hoc approval mechanism. With these procedures in place, both institutions have records of all protocols, informed consent documents, progress reports, and amendments. Both the Einstein IRB (CCI) and the Montefiore Medical Center (MMC) IRB review all adverse events reported for affected protocols. The two IRB's, though structured with separate governance, membership, chairs, and staff, interact through a Joint Conference Committee. This group meets frequently to review policies, procedures, and matters of mutual concern to ensure that the two institutions are operating with nearly identical operational mechanisms. Our aim is to complete the development of a web-based Protocol Application and Tracking System (PATS) for monitoring and coordinating research protocols that will serve two cooperatively operating IRB's, reduce submission errors, track all paperwork (including amendments, adverse events, consent documents and progress reports), and provide data to greatly enhance our human subject protection/quality management programs. This will require infrastructure and technology development for the computedzed tracking of human subject protocols, electronic protocol and adverse events submission, and real-time follow-up of serious adverse events monitoring by the two IRBs. Resources are requested to develop this multiplafform system with a secure database and protected access.

确保人类受试者的安全性在临床研究中至关重要。阿尔伯特·爱因斯坦医学院和蒙蒂菲奥里医学中心长期致力于确保参与临床研究的人类受试者和患者的安全和道德环境。将在爱因斯坦和蒙蒂菲奥里进行的人类受试者研究方案由联邦批准的合作协议管理。根据《合作协议》，两个机构中的一个承担初级审查机构的责任。合作协议安排按照所有联邦准则提供机构监督，避免与调查人员重复工作有关的潜在问题，并使两个机构充分了解每项议定书的状况。指定的初级审查机构接受 负责监督其协议，并通过特设批准机制向其他机构通报情况。有了这些程序，两个机构都有所有方案、知情同意文件、进度报告和修正案的记录。Einstein IRB（CCI）和Montefiore医学中心（MMC）IRB均审查受影响方案报告的所有不良事件。两个IRB虽然有独立的管理、成员、主席和工作人员，但通过联合会议委员会进行互动。该小组经常开会审查政策、程序和共同关心的事项，以确保两个机构以几乎相同的业务机制运作。我们的目标是完成一个基于网络的方案应用和跟踪系统（PATS）的开发，用于监测和协调研究方案，该方案将服务于两个合作运作的IRB， 提交错误，跟踪所有文书工作（包括修正案、不良事件、同意文件和进度报告），并提供数据，以大大加强我们的人类受试者保护/质量管理计划。这将需要开发基础设施和技术，以计算机化跟踪人类受试者方案、电子方案和不良事件提交，以及两个IRB对严重不良事件监测的实时随访。需要资源来开发这个具有安全数据库和受保护的访问的多功能系统。