Protocol Application and Tracking System

在临床研究中，人体受试者安全的保证是至关重要的。阿尔伯特·爱因斯坦医学院和蒙特菲奥里医学中心长期以来一直致力于确保为参与临床研究的人类受试者和患者提供安全和合乎道德的环境。将在爱因斯坦和蒙特菲奥雷进行的人类受试者研究协议由联邦批准的合作协议管理。根据《合作协定》，两个机构中的一个机构承担主要审查机构的责任。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，并有助于使两个机构充分了解每项议定书的状况。指定的初审机构接受 负责监督其议定书，并通过特设批准机制向其他机构通报情况。有了这些程序，两个机构都有所有协议、知情同意文件、进度报告和修正案的记录。爱因斯坦IRB(CCI)和蒙特菲奥里医学中心(MMC)IRB都审查了所有报告的受影响方案的不良事件。这两个IRB虽然结构上有单独的治理、成员、主席和工作人员，但通过一个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，以确保这两个机构的运作机制几乎相同。我们的目标是完成基于Web的协议应用和跟踪系统(PATS)的开发，用于监控和协调研究协议，该系统将服务于两个合作运行的IRB，REDUTE 提交错误，跟踪所有文书工作(包括修订、不良事件、同意文件和进度报告)，并提供数据，以极大地增强我们的人类主体保护/质量管理计划。这将需要开发基础设施和技术，以便对人体受试者方案、电子方案和不良事件提交进行计算机跟踪，并实时跟踪两个机构监测的严重不良事件。需要资源来开发这一具有安全数据库和受保护访问的多格式系统。

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.