New Application

1. JHMeIRB New Application

2. eIRB Login • Login to eIRB at http://e-irb.jhmi.edu.

3. Investigator Home Page • Tool Bar • eIRB Helpdesk • Step by step instructions and tutorials • Contact information • eIRB Survey • submit your feedback to the IRB • What’s New • Learn about updates to the eIRB system, forms, etc. • Grey “Breadcrumb Trail” • Tells where you are in eIRB

4. Investigator Home Page • Left Navigation Bar • Account Management (Non-JHED Users Only) • eIRB Training • My IRB Studies • Create New Application • Studies List • Studies are listed by project type

5. Investigator Tabs • 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• Studies that have been Approved • All My IRB Studies • All approved, disapproved, expired, terminated, disapproved or withdrawn studies with which you are associated

6. Create a New Application • Select My IRB Studies on the left navigation bar. • Click the Create… button to begin an eIRB application.

7. Application Screen • Title Bar • Application number is on the right. • Light Blue Tool Bar • Continue • Saves your work and moves you through the application one screen at a time. • Back • Does not save. It takes you to the previous screen. • Save • Saves your work in progress. • Exit • Does not save. It returns you to the Application Workspace. • Print • Allows you to print the current section of the application.

8. Hide/Show Errors • Hide/Show Errors • Click to split the screen, display errors, and provide links to screens. • Click again to hide the split screen.

9. Jump To Drop Menu • Jump To • Displays list of required screens. • Use the list to navigate to non-consecutive screens.

10. * Required Field • *Required • The red asterisk * indicates a required field that MUST be completed. • The PI will not be able to submit the application until all required fields have been completed. • Be sure to enter a title for the study. Never leave the title field blank. You need a title to access the application.

11. Assign Application Number • Complete all *required fields on the initial screen. • Click Save 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.

12. Help Link • The Help Link icon appear beside each question. • Click the “?” icon to access IRB Regulatory Guidelines and Policies and download forms/templates.

13. Drill Downs • Drill down screens look like a multiple document upload field. • Click Add to open screens requiring additional information.

14. Drill Downs • Drill down screens look like a multiple document upload field. • Click Add to open screens requiring additional information. • Answer the questions. • Click OK.

15. Drill Downs • Drill down screens look like a multiple document upload field. • Click Add to open screens requiring additional information. • Answer the questions. • Click OK. • Save the screen.

16. Update Drill Downs • Click Update to open the screens to upload documents, add, or revise information. • DO NOT click Add and create a new listing to upload documents, add, or revise information to a pre-existing listing. • Select DELETE to remove it. • Save the screen.

17. Exit the Application • Click Save to save the screen. • Click Exit to return to the application workspace.

18. Application Complete • This page displays all study team documents uploaded into the application. • Documents can be downloaded from this screen but not uploaded on this screen. • Click Continue to advance to the last application screen.

19. Application Complete • Click Finish • This returns you to the Application Workspace. • Finish indicates the last page of the application. • You may continue to edit the application until it is submitted.

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

21. Application Workspace • 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.

22. Application Workspace • Left Navigation Bar • Divided into two sections. • View/Print New Application • View/Edit gives access to the existing application. • Printer Friendly View 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.

23. Application Workspace • Left Navigation Bar • Divided into two sections. • Current Activities • Displays a list of activities that may be completed.

24. Application Workspace • Select My Home at the top right and return to the Investigator Home Page.

25. Locate an Application • Select the Researcher Prep tab. • Scroll down to the New Applications section. • Select the application name. • This opens the application workspace.

26. Request Study Team Participation • Select Request Study Team Participation from the Current Activities section. • This opens the Request Study Team Participation Window.

27. Request Study Team Participation • Optional comments may be entered into the text box. • Click OK. This sends out an email notification to everyone on the study team asking them to login to eIRB and complete the Agree to Participate activity. • Study team members may complete the Agree to Participate activity without having received the courtesy email notification.

28. Request Study Team Participation • The PI will receive an email notification when all study team members have agreed to participate. • The History Log may also be checked to determine when all study team members have agreed to participate. • The PI may submit without having received the courtesy email notification, once all study team members have completed the Agreed to Participate activity.

29. Agree to Participate • Study team members may complete the Agree to Participate activity without having received the courtesy email notification. • The Principal Investigator does not complete the Agree to Participate activity. • Submitting the application confirms the agreement of the PI.

30. Agree to Participate • Select the Agree to Participate activity from the Current Activities section of the left navigation bar. • This opens the Agree to Participate window.

31. Agree to Participate • Read the Agree to Participate window content. • Click Yes. • Select whether or not you wish to receive all study-related notifications. • Click OK. • Performing this activity is the equivalent of an electronic signature. • The Principal Investigator does not complete the Agree to Participate activity. • Submitting the change in research confirms the agreement of the PI.

32. Agree to Participate • View the History Log to see that you completed the Agree to Participate activity. • Select My Home to return to the Investigator Home Page.

33. Submit the Application • Select Submit from the Current Activities section. • Only the PI will have the Submit activity. • This opens the submit window.

34. Submit the Application • Submit Window • Add comments or documents ONLY for information NOT included in the application. • Click OK to submit. • This is the equivalent of an electronic signature. • The PI does not complete the Agree to Participate activity. • Submitting the application is the PI’s agreement to participate.

35. Application Submitted • View the History Log to monitor the progress of the application through IRB Review. • Click My Home to return to the Investigator Home Page.

36. Application Submitted • Select the In Process tab. • Scroll down to the New Applications section. • Monitor the progress of your application through IRB Review (Current State). • Upon approval by the IRB the application will appear under the Approved tab.

37. Reviewer Notes • All applications are subject to a Pre-IRB review as well as an IRB reviewer. • Issues that require a response are referred to as “Reviewer Notes”.

38. Reviewer Notes • IRB staff will add reviewer notes to the applicable sections of the eIRB application. • The PI/study team must respond to each reviewer note and make revisions to the application (if applicable) • Select “Click here to respond…” to enter a response.

39. Reviewer Notes • Click “Ok” to save your response. Your response will be highlighted in green when complete.

40. Reviewer Notes • To edit your response, click on “Study Team Response”. • Click OK to save.

41. Reviewer Notes • You can also track and respond to reviewer notes using the “Reviewer Notes” tab on the Application Workspace.

42. Request Extension – Pre IRB • An application may be returned as incomplete after assignment to an IRB and before going to an IRB Committee for review. • The Principal Investigator has 60 days to resubmit the application. • You may seek a 60 day extension of this time limit.

43. Application Workspace – Pre IRB • Click Request Extension - Pre IRB from the Current Activities section. • This opens the Request Extension – Pre IRB window.

44. Request Extension – Pre IRB • Request Extension - Pre IRB window • Click OK. • Completing this activity automatically grants a 60 day extension to respond to the IRB.

45. Request Extension – Post IRB • You may seek an extension for the submission of a response to the IRB issues waiting to be addressed. • You must submit a request in eIRB before the original response due date. • Responses cannot be accepted beyond the deadline without a JHM IRB approved extension. • Only the Principal Investigator may submit the request. 

46. Application Workspace – Post IRB • Click Request Extension – Post IRB from the Current Activities section. • This opens the Request Extension – Post IRB window.

47. Request Extension – Post IRB • Request Extension – Post IRB window • Enter your reasons for requesting an extension. • Click OK. • Completing this activity sends an email notification to the IRB office to consider your request. • You will receive an email response from the IRB.

48. Withdraw Application • Only the PI may withdraw an application. • Click PI Withdraw Study from the Current Activities section. • This opens the Withdraw window.

49. Withdraw Application • PI Withdraw – Researcher Prep • Click OK. • This inactivates the application in eIRB. • If you wish to pursue this study in the future, a new eIRB Application must be created and resubmitted for IRB review. • The study will appear as read-only under the All My IRB Studies tab on the Investigator Home Page.

50. PI Response – Pre/Post IRB • Request Withdraw – PI Response – Pre/Post IRB • Only the PI may withdraw an application. • Click Request Withdraw from the Current Activities section. • This opens the Request Withdrawal window.