EIRB



eIRBReference Guide for Safety Events and CorrespondenceThis guide contains detailed, step-by-step instructions for creating and submitting Safety Events and Correspondence in the eIRB. Safety Event types include:Adverse EventsProtocol Deviation/ViolationsOther Problems/Events Requiring Prompt ReportingCorrespondence types include:Audit or Monitoring ReportsDSMB ReportsFDA/OHRP LettersOther CorrespondenceFor a general introduction to the eIRB, including how to navigate the different workspaces, please see the General Reference Guide. TAble of contents TOC \o "1-3" \h \z \u How to Log In to eIRB PAGEREF _Toc221688020 \h 2How to View Your Task Lists PAGEREF _Toc221688021 \h 2For Study Staff PAGEREF _Toc221688022 \h 3How to Create and Submit Safety Events and Correspondence PAGEREF _Toc221688023 \h 3How to Electronically Sign Safety Events or Correspondence PAGEREF _Toc221688024 \h 12How to Respond to Reviewer Requests PAGEREF _Toc221688025 \h 17Getting Help PAGEREF _Toc221688026 \h 23Technical Support PAGEREF _Toc221688027 \h 23eIRB Home PAGEREF _Toc221688028 \h 23eIRB Email PAGEREF _Toc221688029 \h 23DHTS Help Desk PAGEREF _Toc221688030 \h 23Research Support PAGEREF _Toc221688031 \h 23IRB Office PAGEREF _Toc221688032 \h 23DOCR Office PAGEREF _Toc221688033 \h 23How to Log In to eIRBIn your internet browser, go to the eIRB Home page: .Type your NetID, tab to the password field and type your NetID password, and click the Login button or press the Enter key.Your personal workspace displays.How to View Your Task ListsYour eIRB Task List is designed to show you work that is awaiting your action. Each eIRB role assigned to you has its own Task List.To view the task list, click the white My Home link at the right of the top blue banner.The Task List for the selected role displays in the main section of the window. To view the Task List for a different role, click the role under the My Roles heading in the column at the left. The selected role is shown in the colored banner at the top, and in bold text under the My Roles heading. To return to your Task List from anywhere in the eIRB, click the My Home link again.For Study StaffSafety Events and Correspondence can be created and submitted for Approved, Closed and Re-Opened studies. How to Create and Submit Safety Events and CorrespondenceTo find studies, click the white Studies link in the top blue banner. 2743200-508000Studies on which you are a member of the study team display. 2819400230124000Click the link under the Name column to open the study workspace. The study workspace displays.838200230124000Click New Safety Event or New Correspondence under the Create heading in the column at the left.The first page of the report form displays.5791200401574000Select the radio buttons and enter text to complete the Safety Event Type page. Click Continue to save and proceed.The next page of the report form displays. The pages presented for completion depend on the Safety Event and Correspondence plete the page and click Continue to proceed through all of the pages.When you have Continued through all of the required pages, the form complete page displays.5778500130937000Click Finish.You are returned to the Safey Event workspace. 914400222504000Click the Submit Safety Event button in the column at the left.The Submit Safety Event window displays.53340001932940003352800119253000Click the checkbox and Click OK.The Safety Event or Correspondence moves to the Awaiting Investigator Signatures state and an email notification is sent to the PI.How to Electronically Sign Safety Events or Correspondence601980018732500To view your Task list, click the My Home link in the top blue banner. The task list displays. Study Personnel must be selected under My Roles in the column at the left.3429001273304000Click the link under the Name column to open the Safety Event or Correspondence awaiting Investigator signature.The Safety Event workspace displays.609600239014000Click Electronically Sign Safety Event in the column at the left.The Electronically Sign Safety Event page displays.26828751446530005410200261874000Click the checkbox to confirm and click OK.350520022860000The activity is displayed in the study History, and the submission moves forward to the next reviewer. 609600130048000How to Respond to Reviewer RequestsWhen changes are requested, responding is a two-step process. First, make the changes to the Safety Event or Correspondence. Second, submit the change to notify the reviewer. 60960008064500To view your Task list, click the My Home link in the top blue banner. The task list displays. Study Personnel must be selected under My Roles in the column at the left.3657601327342500533400178752500 Click the link in the Name column to open the Safety Event workspace.358140011430000The request displays in the History folder. 685800165354000To change the Safety Event or Correspondence, click View/Edit Safety Event. Make changes to the report pages as needed, Save and Exit.3886200-11430000Changes appear as entries under the Change Log folder tab. 609600233934000Click Submit Response in the column at the left..The Submit Response window displays. 5517572328739500Enter a response if applicable, and click OK.The activity displays under the History folder tab. The item is removed from your task list. 32766005334000Getting HelpTechnical SupporteIRB HomeSee for help logging in to the eIRB, User Guides, and Frequently Asked Questions (FAQ). eIRB EmailEmail eIRB@mc.duke.edu to contact IRB IT staff for help using the eIRB.DHTS Help DeskCall the DHTS Help Desk at 684-2243 for help with network connectivity, NetID and NetID password. Research SupportIRB OfficeSee for guidance and information from the IRB Office. DOCR OfficeSee for guidance and information from the Duke Office of Clinical Research. ................
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