Getting Started in eIRB: The Basics

1. JHM eIRB Getting Started in eIRB: The Basics

2. eIRB Accounts: JHED Users • JHED User accounts are automatically created upon first login. • No self-registration process is required.

3. 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.

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

5. eIRB Accounts: Non-JHED Users • Only Non-JHED users have the ability to change the password assigned to them. • Select “Account Management” on the left navigation bar and follow the prompts.

6. 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

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Studies that have been Approved • All My IRB Studies • All approved, disapproved, expired, terminated, disapproved or withdrawn studies with which you are associated

8. Create New Application • Available under “My IRB Studies” • Click “Create…” to begin a NEW eIRB application.

9. Create Further Study Action • Locate Approved application • Click on the application name/title to open the Approved application workspace

10. Create Further Study Action • On the left side of the workspace under “Create Further Study Action”, select “Create…”

11. Create Further Study Action • Select the type of Further Study Action (FSA) you would like to create, and click “Continue” to complete the FSA.

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

13. 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”)

14. 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”.

15. 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”.

16. 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.

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

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

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