<p> eIRB Approver User Manual</p><p>Edition 1 (Draft), September 22, 2007 Click Commerce, Inc. Table of Contents Welcome to eIRB...... 3 eIRB Requirements...... 3 eIRB Access...... 3 Obtaining an Account...... 3 What can eIRB Do?...... 4 Information for Departmental Approvers...... 4</p><p>© Copyright 2007. All Rights Reserved. Page 2 of 5 Welcome to eIRB eIRB stands for Electronic Institutional Review Board. The purpose of the eIRB system is to provide a more efficient process of submitting, approving, tracking, and management of IRB study submissions. eIRB Requirements To use eIRB, you are required to have one of the following Internet browsers:  Microsoft Internet Explorer 5.0 or higher (preferred)  AOL 5.0 or higher  Netscape 4.79 or higher  Mozilla 1.6 or higher  Opera 7.10 or higher</p><p>For all Internet browsers, you must have client-side JavaScript enabled. To use the document upload feature and some reporting features, you may be asked to allow Java applets or Active X to run in your browser. You will need to accept the certificate to upload files. ClickCommerce/Webridge Incorporated certifies all items. The eIRB website was designed using a screen resolution of 1024 x 768. It is suggested you use this screen resolution for the optimal display of the eIRB website. eIRB Access The website is available via any Internet connection made by a supported browser. eIRB will be accessible 24 hours a day, 7 days a week.</p><p>Obtaining an Account Investigators and study personnel may self-register to obtain account by following the directions below.</p><p>Go to Self Registration by clicking on the Registration link on the right hand side of the page. Complete the required fields on the form and click register. Upon completion, you will be returned to the home page of the site. </p><p>Please note that all fields with a red asterisk are mandatory; and you must submit a valid email address to be granted access to the system. After your account request has been submitted, you will receive an email with account information. Please allow at least one business day for account creation.</p><p>IRB will handle content and general usage questions. The IRB can be reached at xxx-xxx-xxxx. For technical problems, contact the help desk at xxx-xxx-xxxx.</p><p>Once you have an account, you can navigate to the eIRB site and click the Login link in the top right corner to login. </p><p>© Copyright 2007. All Rights Reserved. Page 3 of 5 What can eIRB Do? Using the new eIRB website, you can:  Create and edit an electronic application for IRB studies  Add other investigators and study personnel to assist in editing the study application.  Prepare the study application via “SmartForms” that present only those sections that are applicable and relevant to your study.  Attach scanned or electronic documents to the study.  Print out the application in a printer-friendly version.  Validate the application before submission to catch common mistakes and reduce the number of changes required after submission.  Submit a single application electronically to the IRB.  Track the progress of the application as it is automatically routed for review and signoff to the appropriate organizations (i.e., ancillary approvers and department heads) before being received by the IRB.  Receive email notifications anytime a reviewer sends the application back for requested changes.  Receive the approval letter via email once the study is approved. A copy of the approval letter and approved consent forms will be posted online with the study and available for download at anytime.  View a time stamped log of all changes made to the application and any correspondence sent between the study team and the IRB.</p><p>Information for Departmental Approvers Personal Folder Elements Top Navigator Bar o Your Name: Access/Modify personal contact information. Change password o My Home: Your personal folder (this page) o Logoff: Ends your eIRB session</p><p>Tabbed Area o My Inbox: Displays all new study applications that need your department approval before being accepted by the IRB</p><p>© Copyright 2007. All Rights Reserved. Page 4 of 5 o Studies: Lists all of studies in the system belonging to your department o Reports: Reports list</p><p>Study Workspace o Current State: Indicates where the study is in the IRB review/approval process o View Study: Opens the application smart forms o Printer-Friendly Version: Opens page displaying all applicable sections of the application in a version that will easily print on most printers o My Activities: Displays all available actions you can do at this point o Department Reviewer Approve Protocol: Records your signature indicating that this study proposal has your approval o Department Reviewer Request Changes: Sends the study proposal back to the study team for changes indicated by you o Summary View: Displays summary information about the study proposal. This view will change as new information is supplied (i.e., IRB administrator, assigned IRB meeting date). o History: Log of all actions performed on this study proposal o Documents: Quick links to common documents attached to the application o Pre Review Status: Indicates status of all required division/department approvals</p><p>Steps to review a new study application 1. Login with your username and password. 2. Open the study from My Inbox by clicking on the name. 3. In the study workspace, click the View Study icon to open the smart form application. - OR -Click the Printer Friendly Version icon to open the entire application in a printable version. 4. Review the study application and attached documents. 5. Exit the application to return to the study workspace.</p><p>If changes are required: o If you would like to request changes in the application, click the Department Reviewer Request Changes activity. o Indicate the necessary changes in the multi-line text box, or attach a MS Word document containing your requested changes. o Click the OK button to submit the changes request to the investigator team.</p><p>If no changes are required: o If you would like to approve the study, click the Department Review Approve Protocol activity. o Make sure the departments you are approving for are checked. o Click the OK button to submit the approval of the study.</p><p>© Copyright 2007. All Rights Reserved. Page 5 of 5</p>