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Continuing Review for Convened and Expedited IRB Applications

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  1. JHM eIRB Continuing Review

  2. Continuing Review • Continuing Reviews must be submitted annually and are required for all Convened and Expedited applications. • Continuing Reviews must be submitted prior to the expiration date. Failure to do so will result in the expiration of the study. • If you wish to continuing active enrollment or active follow-up of participants, you must submit a New Application for review and approval by the IRB.

  3. Create Continuing Review • Select My IRB Studies from the left navigation bar. • Locate the Approved tab 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.

  4. Create Continuing Review • Under Current Activities, locateCreate Further Study Action. • Click Create...

  5. Create Continuing Review • 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.

  6. Continuing Review Screens • Complete each screen. • Click Continue to save the current screen and advance to the next screen.

  7. * 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.

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

  9. Finalize Continuing Review • 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.

  10. Continuing Review 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.

  11. Continuing Review 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.

  12. Continuing Review 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.

  13. Continuing Review Workspace • Left Navigation Bar • Divided into two sections. • 2 - Current Activities • Displays a list of activities that may be completed.

  14. Continuing Review 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.

  15. Continuing Review Complete • Click Submit when the application is ready to IRB review (only the PI will have the Submit activity).

  16. Continuing Review Workspace • Select My Home to return to the Investigator Home Page.

  17. Locate/Track Continuing Review • Option 1: • Select the appropriate tab. • Scroll down to the Continuing Review (Green)section. • Select the application name. • This opens the application workspace.

  18. Investigator Home Page • Option 2: • Select the Approved tab on the Investigator Home Page. • Scroll down to the Continuing Review section. • Select the study name. • This opens the application workspace.

  19. Application Workspace • Select the Further Study Action tab. • Scroll down to the Continuing Review section. • Select the application name. • This opens the application workspace.

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