eIRB 101: Prepare and Submit an eIRB Application

1. eIRB 101: Prepare and Submitan eIRB Application jhmeirb@jhmi.edu

2. Topics • Accounts and Websites • Investigator Home Screen • Application Workspace • Application Screens • Study Proposal • Consent Form • Application Complete • Respond to IRB Issues • Create a Further Study Action

3. IRB Website http://www.hopkinsmedicine.org/institutional_review_board

4. Compliance Training • All compliance training courses are available online through the Hopkins myLearning website*. • Be sure to save and print your certificates at the time you complete each course. *The IRB does not monitor or maintain this website. Contact the eLearn at elearn@jhmi.edu for assistance.

5. Technical Training • eIRB Training Dates • Must have an eIRB account to register

6. Getting Started in eIRBeIRB Help Guide, Instructions, and Information

7. Getting Started in eIRB eIRB Wizards

8. Link to eIRB Login

9. eIRB Accounts • All users of eIRB must have an account. • JHED User accounts are automatically created upon first login. • Non-JHED Users must self-register for an account.

10. eIRB Accounts • Non-JHED User accounts can be created via a link on the eIRB login page at https://e-irb.jhmi.edu.

11. eIRB Accounts • Getting Started in eIRB • IRB Compliance Training Requirements • IRB Homepage • eIRB Updates

12. eIRB – http://e-irb.jhmi.eduLogin with JHED ID/User ID and Password

13. Investigator Workspace

14. Investigator Workspace

15. Investigator Workspace • Blue Title Bar • My Home – returns you to this screen. • Black Tool Bar • eIRB Helpdesk • Step by step instructions and tutorials • Contact information • eIRB Survey • Submits your feedback to the IRB. • “What’s New” • Provides a summary of eIRB updates.

16. Investigator Workspace • Left Navigation Bar • My IRB Studies – lists all of your studies. • eIRB Training – lists all eIRB training classes open for registration. • OPC Disclosures – connects you to the Office of Policy Coordination screens. • Create a New Application button.

17. Investigator Workspace • Investigator Tabs • Action Required – your previously submitted studies awaiting PI action. • Researcher Prep – your studies that have never been submitted. • In Process – your studies awaiting Pre-IRB or IRB action. • Approved – your approved studies. • All My IRB Studies – all your studies in preparation, in process, approved, disapproved, expired, terminated, or withdrawn.

18. Investigator Workspace • Studies List • Your studies are listed by type. • New Application • Change in Research • Continuing Review • Protocol Event • Termination Report • Emergency Use • Click the study name to open the study workspace.

19. Application Workspace

20. Application Workspace • Application Waiting to be Submitted • Disappears upon submission of the application by the PI. • Study Vital Statistics • Displays the study title, number, PI, IRB Committee, review type, last scheduled review, expiration date, and original approval date. • Application Current Status • Displays the application’s current state in the submission/review process.

21. Application Workspace • Left Navigation Bar (Divided into three sections) • View/Print New Application • View/Edit Application – gives access to the existing application. • Printer Friendly View – displays a scrollable version of the application with the option to print. • View Differences – lists changes made to the application since the previous submission.

22. Application Workspace • Left Navigation Bar • Divided into three sections. • Progress Application Screens • View Data Entry Progress – displays a list of application screens showing which are complete, incomplete, or not required. • Current Activities • Displays a list of activities that may be completed.

23. Application Workspace • Workspace Tabs • Provide quick access to study-related information. • Will appear as needed. • History Log • Reflects completed activities. • Review List • Displays the review date, review type, meeting outcome, letter, and response.

24. Application Screens

25. 1 – General Information • Clicking the “Create an Application” button on the Investigator Home Page will bring you to the first page of the application.

26. * Required Field • Red asterisk * = Required field. • The PI will not be able to submit the application until all required fields have been completed. • Always enter a title for the study. Never leave the title field blank. You need a title to access the application.

27. Application Number Assignment • In order to be assigned an application number, you must: • Complete all *required fields on the first screen (1 – General Information). • Be sure to enter a title for the study. • Click Continue to advance to the next screen.

28. 1 – General Information • eIRB application numbers begin with “NA”. • Located in the upper right corner of the application screens. • Save will not work until the application number is assigned by eIRB.

29. 1 – General Information • Blue Title Bar • Application number is on the right.

30. 1 – General Information • 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 - displays a printer friendly view of the screen with the option to print.

31. Hide/Show Errors • Light Blue Tool Bar • Continue • Back • Save • Exit • Print • Hide/Show Errors • Click to split the screen, display errors, and provide links to screens. • Click again to hide the split screen.

32. Jump To Drop Menu • Light Blue Tool Bar • Continue • Back • Save • Exit • Print • Hide/Show Errors • Displays errors and provides links to screens. • Jump To • Displays list of screens used. • Use the list to navigate to non-consecutive screens.

33. Help Tools • Help Tools appear beside each question.

34. Help Tools • Help Tools appear beside each question. • Click the Regulatory Guidelines icon to access IRB Guidelines and Policies, and to download forms. • Click the Information Technology icon to access step by step technologic instructions.

35. Select Principal Investigator • Click the Information Technology icon for step by step directions.

36. Select Principal Investigator • Click the Information Technology icon for step by step directions.

37. Select Principal Investigator • Click the Information Technology icon for step by step directions.

38. Select Study Team Member • Click the Information Technology icon for step by step directions.

39. Select Study Team Member • Click the Information Technology icon for step by step directions.

40. 2- Study Team Compliance Training • Verify compliance training information (required trainings, completion dates) in Q. 1.0 • It is not necessary to send compliance training certificates in advance of an eIRB submission. • If compliance training dates are incorrect/missing,upload copies of training certificates into Q. 2.0. IRB staff will enter the dates into the eIRB system upon submission of the application.

41. 2- Study Team Compliance Training • Non-Hopkinsstudy team members? Upload copies of their Human Subjects Research (HSR) compliance training certification. • We will accept compliance training certification from: • their local institution • Collaborative Institutional Training Initiative (CITI), • or another institution such as the National Institutes of Health (NIH).  

42. 9 - Support InformationMonetary and Material Funding or material source not listed? Email jhmeirb@jhmi.edu with the name of the funding or material source and we will add it to eIRB.

43. Add/Upload Revised Documents • Many documents or forms will be uploaded into eIRB. • Click the Information Technology icon for step by step directions.

44. Add/Upload Revised Documents • Many documents or forms will be uploaded into eIRB. • Click the Information Technology icon for step by step directions.

45. Documents and Forms • Things to remember… • Do not delete documents or forms once the application has been submitted. • IRB templates/forms must be downloaded from within the eIRB application/IRB site. • Only electronic documents/forms are accepted in eIRB. • Paper copies of documents/forms must be scanned and converted into electronic copies. • Need a high-speed scanner to convert paper documents/forms into Adobe Acrobat (.pdf) files. Call 410-955-3008 or send an email to jhmirb@jhmi.edu to schedule an appointment.

46. Study Proposal

47. 6 – Protocol Information • Select the type of protocol you wish to submit. • Click the icon.

48. Download eForm A • Right click the link to eForm A. • Save the form to your local drive. • Use a simple naming convention, including the upload date. • ex. eFormA_050210.doc • Complete eForm A and save it to your local drive.

49. Upload Protocol • The protocol field is a single upload field. • It does not display the blue/gray bars that indicate a multiple upload field. • Click the Information Technology icon for step by step directions.

50. Upload Protocol • The protocol field is a single upload field. • It does not display the blue/gray bars that indicate a multiple upload field. • Click the Information Technology icon for step by step directions.