I just Submitted to the IRB… What now?

1. I just Submitted to the IRB… What now?

2. Have I really submitted it??(Not in this case - Click the yellow box)

3. Click on the Routing Assignment list icon

4. You have not clicked “Save and Continue” to begin routing

5. Signatures are still needed:“Waiting for PI signoff”

6. Signatures are still needed:“In process” vs. “completed”

7. Check to see whether the IRB has received it

8. YES! I did it!

9. After an IRB analyst is assigned,how do I track it?

10. Click “Track Location”

11. Ok, this is whom I should call with questions.

12. Reviewers have completed their reviews

13. I need to respond to the Irb!Click to open from your “Incomplete tasks”

14. Or: Go to “Project assistant,” then to “My Projects”

15. Under “Request Type,” click the hyperlink

16. PI response form

17. Scroll down to review provisos

18. Scroll down to revise application& Click on the green bar

19. Click “add revision” in order to edit your application

20. If you see “save and continue,” you can edit your application

21. Don’t forget to check the box before clicking “save attachments”!

22. Check to ensure the new versionshows up under green bar

23. Click on the green bar to revise your consent form

24. Click “add revision” in order to edit your consent form

25. Click “Check-out document”

26. A pop-up window will ask you to open or save

27. click “Save”

28. Don’t forget to click “Complete checkout”

29. After editing, click “check-in document”

30. Browse and save your edited consent form

31. Don’t forget to check the box before clicking “save attachments”!

32. Check to ensure the new versionshows up under green bar

33. Answer the 3 questions in the pi response form before saving & routing

34. I have received approval!You can find your letter in “Project Correspondence” or “submissions history”

35. Your letter in “Project correspondence”

36. your letter in “submissions history”

37. Click on “Add new form” to create a form 2 for revision

38. Screen 1 of the Form 2 - just answer and click “Save and continue”

39. Things to remember after submitting an application to the IRB • Form 1 (new application): Gently remind your investigators and department chairs to sign off. • Don’t forget to save all the way through the routing pages. • Check your workflow tracking to make sure the IRB received your submission. • If you have questions, look up your analyst and call her. • Provisos can be found in your letter (project correspondence or submissions history) or in the PI Response form. • You/your sponsor can disagree with a proviso; call and let’s talk about it!

40. Things to remember after submitting an application to the IRB • In your PI Response form, remember to check the box to the left of your revised application and consent form before you save that page. • Visit our website: Getting Started page, iMedRIS guides, FAQs, policies, and more! • Check the deadline schedule for full Board submissions - submit 3 weeks in advance. • In general, a full Board submission will be returned to you with recommendations about 1 ½ weeks before the meeting. • Exempt applications: expect a response in 5-7 business days. • Expedited applications: expect a response within 2 weeks. • All correspondence from iMedRIS goes directly to your UT email address!

41. Things to remember Once your application has been approved • ANY CHANGE (even minor) to your study must be reviewed and approved by the IRB before the change is implemented. • Remember to submit adverse events and major protocol deviations to the IRB for review. • If your study is expedited or full Board (check your IRB #), you must submit a continuation/renewal form (Form 3) every year, 3 weeks before your expiration date. • You cannot enroll above the number of subjects approved for your study - a subject is considered enrolled after signing a consent form, even if they drop out or do not pass screening tests. • The consent form must be signed by the PI within 72 hours of the subject and person obtaining consent signing it.