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Efficient Protocol Event Report Submission Guide

Learn how to create and submit Protocol Event Reports for active IRB-approved studies. Follow step-by-step instructions for completing and finalizing reports. Utilize the Workspace features for tracking and monitoring progress.

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Efficient Protocol Event Report Submission Guide

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  1. JHM eIRB Protocol Event Report

  2. Protocol Event Reports • Protocol Event Reports may be submitted for active IRB approved studies. • Only oneProtocol Event Reports may be submitted to the IRB in a single submission. • Problem Event Reports may be submitted at any time.

  3. IND Safety Reports • IND Safety Reports are not protocol events. • IND Safety Reports with no changes to consent form(s) or protocolare submitted on the Application Workspace via the “Submit IND Safety Report” activity. • IND Safety Reports with changes to consent form(s) or protocolare submitted as a Change in Research.

  4. Create Protocol Event Report • Select My IRB Studies from the left navigation bar. • Locate the Approved tab (Or the All My IRB Studiestabfor Terminated/Expired applications) on the Investigator Home Page. • Scroll down to the New Applications section. • Select the name of the currently approved study. • This opens the application workspace.

  5. Create Protocol Event Report • Under Current Activities, locateCreate Further Study Action. • Click Create...

  6. Create Protocol Event Report • Select the type of FSA to be createdand select Continue. • You can only select one FSA at a time. • Once the FSA has been created, you can return to this screen, following the previous steps, to select a different type of FSA or another Protocol Event.

  7. Protocol Event Report Screens • Answer the five questions on Page 1 of the Protocol Event Report. • If you answer “yes” or “uncertain” to any of the questions, you must click “Continue” and complete a Protocol Event Report. • If you answer “no” to all of the questions, you do not need to submit this event as a Protocol Event (refer to red instructions for additional information)

  8. Protocol Event Report Screens • Complete each screen. • Click Continue to save the current screen and advance to the next screen.

  9. * Required Field • The red asterisk * indicates a required field that MUST be completed. • You will not be able to submit the application until all required fields on each screen have been answered.

  10. Help Link • The Help Link icon appears beside each question. • Click the icon to access IRB Regulatory Guidelines and Policies and download forms/templates.

  11. Finalize Protocol Event Report • Click Finish • This returns you to the application workspace. • Finish indicates the last page of application. • You may continue to edit the continuing review until it is submitted.

  12. Protocol Event Workspace • Application Waiting To Be Submitted • Purple text disappears upon submission. • Study Vital Statistics • Displays important information such as the study title, date submitted and last scheduled review. • Current Status • Displays the current state of the change in research in the submission/review process.

  13. Protocol Event Workspace • IRB Review Items • Displays the review date, review type, outcome, and letter sent. • Workspace Tabs • History Log • Reflects completed activities. • Reviewer Notes • Displays a collective list of IRB issues that require a response by the study team.

  14. Protocol Event Workspace • Left Navigation Bar • Divided into two sections. • 1- Project Editor • View/Edit gives access to the existing application. • Printer Friendly displays a scrollable version of the application with the option to print. • View Differences lists changes made to the change in research since the previous submission.

  15. Protocol Event Workspace • Left Navigation Bar • Divided into two sections. • 2 - Current Activities • Displays a list of activities that may be completed.

  16. Protocol Event Workspace • View the Current Status box to monitor progress through the IRB review process. • Select View/Edit to open an existing application. • Use the Current Activities to submit/withdraw the application. • View the History Log to track activities. • Use the Review List to retrieve the review outcome letter.

  17. Protocol Event Complete • Click Submit when the application is ready to IRB review (only the PI will have the Submit activity).

  18. Protocol Event Workspace • Select My Home to return to the Investigator Home Page.

  19. Locate/Track Protocol Event Report • Option 1: • Select the In-Process tab. • Scroll down to the Protocol Event Report (Red)section. • Select the application name. • This opens the application workspace.

  20. Investigator Home Page • Option 2: • Select the Approved tab on the Investigator Home Page. • Scroll down to the Protocol Event Report section. • Select the study name. • This opens the application workspace.

  21. Application Workspace • Select the Further Study Action tab. • Scroll down to the Protocol Event Report section. • Select the application name. • This opens the application workspace.

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