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www.absa.org Applied Biosafety Vol. 15, No. 3, 2010 Software applications offer a number of significant advantages to institutions that review many research protocol applications per month including: • A traceable record of the process for each • Electronic filing of all pertinent materials • Consistency of the review process • Reduced administrative workload for research committee coordinators However, available software solutions are typically expensive, may not be customizable to meet specific institutional needs, and may represent a potential liability with respect to long-term support (custom third-party software). Five years ago, Environmental Health and Engineering, Inc. (EH&E) began utilizing Microsoft SharePoint as a platform for the development of environmental health and safety (EHS) and biosafety applications to support EHS and biosafety programs in several large research institutions managed by EH&E. We have recently expanded its use to Institutional Biosafety Committee (IBC) program management. Microsoft SharePoint is a web-based collaboration platform designed to allow project teams to design customized project sites where they can share documents and information, and track project progress. We have found it highly effective at managing program documents and data for very complex programs, as well as communicating program status in an organizational format consistent with the needs of each institution. SharePoint is also gaining popularity, with SharePoint servers (and consequently SharePoint Information Technology support) found in most research institutions. Therefore, SharePoint represents a low-cost (and common) potential resource for many applications. Here I will talk specifically about a SharePoint IBC application, but the same system could include Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) functionality. Three primary features are associated with SharePoint that are critical for this application: its ability to utilize web-based data-entry forms to collect and disseminate information, its inherent system of permissions allowing levels of user access, and its ability to automate workflow processes. In our experience, the primary benefit realized with the application is the automation of administrative tasks associated with the IBC protocol approval process. Automation frees the IBC administrator from the myriad of tasks associated with continuous oversight, which is necessary to keep the process moving and participants informed. And in every case the automation resulted in significantly fewer days from receipt to approval, thus a more efficient review process. But we also found that while the major steps of the review process are quite prescribed, many variations exist due to cultural differences within each institution. The ultimate success of the application depends upon its ability to mirror (or improve if necessary) the process in place. Development of the application begins with careful modeling of the actual review process used within the institution. We find creation of a flow chart a useful start, and then drilling down to determine the exact sequence of events comprising each stage or control point in the process (Figure 1). The control points are breaks in the process at which the biosafety officer (BSO) reviews the previous step and makes a manual determination as to the next step in the process. The result is a sequence of process stages with detailed information concerning the input required, the personnel involved, the timeframe required for action, and the system response for all possible actions. Permissions associated with each stage are also determined during this process. The institutional forms used to submit research applications, amendments, annual reviews, etc. are then transferred to web format (typically from Microsoft Word) via InfoPath (a Microsoft form-generation program). Data entry and viewing are performed in the original format, making it easy for reviewers to adapt to the electronic forms. Forms are then associated with additional data fields required for protocol review as determined in the modeling phase. For example, comments fields may be added to track reviewer comments, defined control points are choices in a “Stage” field, and a field may be added to collect the names of one or more designated reviewers (Figure 2). Permissions are used to determine what fields researchers, reviewers, and the BSO can view or edit as part of this effort. E-mail alerts and rules can be developed and associated with the individual workflows comprising each stage in the review process. For example, selection of an “Initial Review” stage may trigger e-mail alerts to all committee members requesting their input as to whether a protocol requires a full committee review within 4 business days. When either a committee member makes this recommendation or the deadline is reached, the BSO receives an e-mail notice that the stage is complete. As Letter to the Editors

Managing Your Research Protocol Process via Microsoft SharePoint: A Customizable and Cost-effective Solution