12. Left Navigation Bar – Account Management (Non-JHED Users Only) – eIRB Training – My IRB Studies – Create New Application Welcome Message – Link to Archive eIRB website Studies List – Studies are listed by project type

13. Action Required (default tab) – Studies that have been returned for PI response Researcher Prep – Studies that have never been submitted In Process – Studies awaiting Pre-IRB or IRB review Approved – Studies that have been Approved All My IRB Studies – All approved, disapproved, expired, terminated, disapproved or withdrawn studies with which you are associated.

15. Select My IRB Studies on the left navigation bar. Create… Click the Create… button to begin a NEW eIRB application.

17. Current Status – Displays the current status of the application in the submission/review process. Study Vital Statistics – Displays the study title, number, PI, IRB committee, review type, date submitted and last scheduled review. Application Waiting to be Submitted – Purple text will disappear upon submission of the application.

18. IRB Review List – Displays the review date, review type, outcome, and letter sent (only if the application has undergone IRB review – not IRB pre-review). Workspace Tabs – Provide quick access to study- related information. – Will appear as needed. – History Log  Reflects completed activities. – Reviewer Notes  Displays a collective list of IRB issues that require a response by the study team.

19. Left Navigation Bar – Divided into two sections. 1 – Project Editor – “View/Edit” provides editing access to the application. – “Printer Friendly” displays a scrollable version of the application with the option to print.  Uploaded documents may be opened and printed separately from this view. – “View Differences” lists changes made to the application since the previous submission.

20. Left Navigation Bar – Divided into two sections. 2 - Current Activities – Displays a list of activities that may be completed.

24. Complete all *required fields on the initial screen. Click Save or Continue to create the application and assign it an IRB number. eIRB application numbers begin with “IRB” and may be found in the upper right corner of the application screens.

27. – Hide/Show Errors  Click to split the screen, display errors, and provide links to screens.  Click again to hide the split screen.

28. – Jump To  Displays list of required screens.  Use the list to navigate to non- consecutive screens.

29. The Help Link icons appear beside each question. – Click the help icon to access IRB Regulatory Guidelines and Policies and download forms/templates.

30. Example: Click the Help Link icon for guidance.

31. Helpful information will appear above or below the question.

49. Q: What happens when the IRB wants me to make changes to my protocol? Download the previously uploaded protocol – make a tracked changes copy and a new clean copy. Q3. Click Update to upload a new clean version. Q4. Click ADD to upload the tracked changes version.

58. Click Add to upload the completed consent form. Only one version of each consent form should be visible.

60. Click Update to upload the tracked changes version into the consent form field. This replaces, but does not delete, the previous version of the same consent. A clean version of the consent form is not needed. A clean version of the consent form is not needed.

61. The IRB will upload a clean, approved consent directly into this application question. This consent is to be used with changes in research. Remember: Only one version of each consent form should be visible.

67. Select My Home at the top right and return to the Investigator Home Page.

98. Upon approval, IRB staff will provide you with clean, unstamped versions of your documents. Documents are uploaded directly into the application under the appropriate questions.

99. These documents are to be used with changes in research. Only one version (clean on top, tracked and previous versions underneath) of each document should be visible.

100. Upon approval, IRB staff will also provide you with IRB stamped versions of your documents. Select the Stamped Documents tab. Click on the document name to open. Use these stamped documents with study participants.