eIRB 101: Prepare and Submit an eIRB Application

1. JHMeIRB eIRB 101: Prepare and Submitan eIRB Application

2. Topics • Accounts and Websites • Investigator Home Screen • Application Workspace • Application Screens • Study Proposal • Consent Form • Application Complete • Respond to Reviewer Notes • 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.

5. Technical Training • eIRB Tutorials and Registration for Upcoming Training • Must have a myLearning account to register.

6. Getting Started in eIRB Review Type Wizards

7. Link to eIRB Login

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

9. eIRB Accounts: JHED Users • If you forget your JHED ID or JHED password: • Use the links (i.e., Forgot Password?) below, or • contact JHED directly at jhed@jhmi.edu or call the JHED IT Support Center at 410-955-HELP.

10. eIRB Accounts: Non-JHED Users • Non-JHED Users must email the eIRB help desk (jhmeirb@jhmi.edu) to set up an account.

11. Investigator Workspace

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Studies that have been Approved • All My IRB Studies • All approved, disapproved, expired, terminated, disapproved or withdrawn studies with which you are associated.

14. 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.

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

16. Application Workspace

17. Application Workspace • 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. 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.

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

21. Application Screens

22. 1 – General Information • Clicking the “Create…” button on the Investigator Home Page will bring you to the first page of the application.

23. * 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.

24. Assign Application Number • 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.

25. 1 – General Information • eIRB application numbers begin with “IRB”. • Located in the upper right corner of the application screens. • Save will not work until the application number is assigned by eIRB.

26. Application Screen • Title Bar • Application number is on the right. • Light Blue Tool Bar • 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. • Continue • Saves your work and moves you through the application one screen at a time.

27. 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.

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

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

30. Select Principal Investigator • Example: Clickthe Help Link icon for guidance.

31. Select Principal Investigator • Helpful information will appear above or below the question.

32. 2 - Study Team Compliance Training 2 – Study Team Compliance Training • Verify compliance training information (Q1) • Do not send compliance training certificates in advance of an eIRB submission. • If compliance training dates are incorrect or missing,upload copies of training certificates into Q2. • IRB Staff will enter the dates into the eIRB system upon submission.

33. 2 - Study Team Compliance Training • Non-Hopkins affiliated study team members are also required to upload a copy of their human subjects research (HSR) compliance training certification.

34. 8 - 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.

35. Add/Update/Delete Documents Add Documents You must select “Add ” to: • Upload a NewDocument

36. Add/Update/Delete Documents UpdateDocuments You must select “Update” to: • Upload a Reviseddocument • View the history of a document • Delete a document (4. change dropdown from “Submitted” to “Deleted”)

37. Add/Update/Delete Documents Delete Documents • Use “Update” to change the status of the document to “Deleted” • Click “OK” • A “strikethrough” will appear through the document name. • Click “Update” to upload the correct document • Remember to change the status to “Submitted” before clicking “OK”.

38. Documents and Forms • Things to remember… • IRB templates/forms must be downloaded from within the eIRB application/IRB site. Use the Help Link icon to download the latest versions of templates/forms. • Only electronic documents/forms are accepted in eIRB.

39. Drill Downs • Drill downs are pages within pages. • Click Add to open screens requiring additional information.

40. Drill Downs • Answer the questions. • Scroll down. • Click OK at the bottom right corner.

41. Drill Downs • Save the screen or Click continue to save and move forward.

42. 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. • Save the screen.

43. Study Proposal

44. 6 – Protocol Information • Q1 - Select the type of protocol you wish to submit. • Click the icon to download the JHM-IRB eForm A (if applicable)

45. Download eForm A • Right click the link to JHM IRB eForm A. • Save the template to your local drive. • Use a simple naming convention, including the upload date. • ex. eFormA_010114.doc • Complete the form and save it to your local drive.

46. Upload Protocol • Q3 - Click Add to upload the completed eForm A.

47. Upload Protocol • Use the “Browse” button to locate the document. • Once the document is located, select the document and click “open”. • Click“OK” when finished.

48. Upload Protocol • For new applications that have not been submitted, only a clean copy of the protocol is required. • Save the screen.

49. Upload Revised Protocol • 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.

50. Delete Documents If you upload the wrong document… • Use “Update” to change the status of the document to “Deleted” • Click “OK” • A “strikethrough” will appear through the document name. • The status of the document will read “Deleted”.