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Termination/Post Termination Reports

JHM eIRB. Termination/Post Termination Reports. Termination/Post Termination Reports. Termination report: Study activity is completed and Access to study identifiers (if applicable) is no longer required for data analysis or manuscript writing. Post Termination Report:

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Termination/Post Termination Reports

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  1. JHM eIRB Termination/Post Termination Reports

  2. Termination/Post Termination Reports • Termination report: • Study activity is completed and • Access to study identifiers (if applicable) is no longer required for data analysis or manuscript writing. • Post Termination Report: • Submission of information relevant to the study after the study is terminated or expired.

  3. Create Termination 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.

  4. Create Termination Report • Under Current Activities, locateCreate Further Study Action. • Click Create...

  5. Create Termination 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.

  6. Termination Report Screens • Select the type of report • Termination Report • Post-termination Report

  7. Termination Report Screens • Complete each screen. • Click Continue to save the current screen and advance to the next screen.

  8. * 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.

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

  10. Finalize Termination 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.

  11. Termination Report 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.

  12. Termination Report 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.

  13. Termination Report 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.

  14. Termination Report Workspace • Left Navigation Bar • Divided into two sections. • 2 - Current Activities • Displays a list of activities that may be completed.

  15. Termination Report 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.

  16. Termination Report Complete • Click Submit when the application is ready to IRB review (only the PI will have the Submit activity).

  17. Termination Report Workspace • Select My Home to return to the Investigator Home Page.

  18. Locate/Track Termination Report • Option 1: • Select the In-Process tab. • Scroll down to the Termination Report (Black)section. • Select the application name. • This opens the application workspace.

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

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

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