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Protocol Event Report

JHM eIRB. Protocol Event Report. Protocol Event Reports. Protocol Event Reports may be submitted for active IRB approved studies. Only one Protocol Event Reports may be submitted to the IRB in a single submission. Problem Event Reports may be submitted at any time. IND Safety Reports.

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Protocol Event Report

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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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