Protocol Application and Tracking System

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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.