McLean Hospital is a private psychiatric hospital located in Belmont MA, a Boston suburb. McLean is a member of Parmers HealthCare Systems (an affiliation of Boston-area hospitals including the Massachusetts General Hospital and the Brigham and Women's Hospital), is a corporate affiliate of the Massachusetts General Hospital, and is the largest psychiatric teaching hospital of Harvard Medical School. In fact, McLean has one of the world's largest research programs in psychiatry. A hallmark of McLean research is its synthesis of scientific and clinical expertise and its involvement of a high proportion of patients and staff. McLean's Institutional Review Board currently monitors more than 310 active clinical studies. McLean Hospital maintains an Institutional Review Board to review research protocols involving human subjects and to evaluate both risk and protection against risk for those subjects. The Human Subjects Program (HSP) is an office overseen by McLean Research Administration. Because of the length of time that a human subject protection program has been in place at McLean, and because of technology advances during that same timeframe, our archiving system for the mandated retention of documents is outdated and inadequate. To remedy this situation, and to provide infrastructure for upgrading current and future record keeping and retention, we propose the acquisition of a Digital Document Management System (hardware, software and professional support services) from IDP Healthcare Solutions. We propose a local area network system of computers capable of interfacing with both the hospital and research networks, which will allow us to move to electronic protocol submission and status tracking, allow easier monitoring of expedited approvals, more efficient receipt and response to adverse event reporting, and coordination of activities across the Parmers IRB sites. We have selected software from ProIRB Plus, Inc., that will allow us to monitor and follow up on informed consent revisions, track adverse events and IND reports, docket agenda items for review, and maintain an active and updated database of investigators, sponsors and study coordinators. Purchase of these software and hardware systems described above will not only allow us to manage McLean Hospital's local Human Subject Program better, but will also facilitate IRB activities across Partners sites, allowing us to integrate linked compliance and oversight, and allowing us better access and communication with the larger Partners panels and the Partners Human Research Protection infrastructure.
