1. AURA-IRB Training 1

2. Introductions 2 AURA-IRB Trainer Candace Washington cdwashington@uchicago.edu 2-2925 Your Name Department If you could be any Rockstar who would it be???

3. Our OVERALL Purpose for today! 3 Shorten the learning curve Get you up to Speed in AURA-IRB And Ultimately...

4. 4 Make you ROCK STAR! Disclaimer: We are only responsible for your AURA-IRB Rockstardom !!!, all other rockstar ambitions are must be pursued outside of this class.

5. 5 What is exciting about this

6. K-W-L 6 K What do YOU know about AURA-IRB? W What do YOU want to know?

7. Agenda 7 Websites/IRB Resources System Roles System Notifications IRB Listserv System Overview  Navigation  Activities/ Workflow  Submissions (Initial, Amendment, Continuing Review, UP)

8. At the END of this session…. 8 You will be able to: Navigate AURA IRB Create a new study Forward for PI endorsement Respond to IRB comments Link FP to Protocol Locate your approval letters Submit Amendments, Continuing Reviews, & UP’s

9. Websites/Resources 9

10. AURA IRB Roles 10

11. Roles 11 Your roles in AURA-IRB will be set-up for you  Registered User  Everyone who gets a paycheck from the University will have this role automatically  You’ll be able to log into the system  Additional roles will be predetermined by the AURA-IRB Functional Team in conjunction with the appropriate IRB Director(s).  If you need additional roles/access in the system  Email the AURA Help Desk and they will coordinate the proper addition/access accordingly

12. AURA-IRB Reporting 12 Questions about the data warehouse? How to pull reports? AURA-IRB Reporting Help Desk: auradw-help@lists.uchicago.edu

13. Notifications 13

14. System Notifications 14 AURA will normally send notifications when your action/attention is required  You may click through this notification to access the study’s workspace to perform the necessary review/endorsement/action  What email address will the AURA-IRB system notifications come from?  aura-irb@uchicago.edu aura-irb@uchicago.edu

15. AURA Listserv 15

16. AURA Listserv 16 The new AURA-IRB listerv: aura- irb@lists.uchicago.eduaura- irb@lists.uchicago.edu  Communicates important announcements to the IRB community.  Training offerings, help tips, system enhancements and other related information

17. AURA Help Desk 17

18. AURA Help Desk 18 AURA has dedicated support staff  Email AURA-Help@uchicago.edu for system related questions.AURA-Help@uchicago.edu  I can’t log in from off campus. Help!?  I can’t find the study I started yesterday. Help!?  How do I add people to my research team?  How do I route a study to the IRB for review?  Where do I find my approval letter?  You may also email non-system related questions and the HD will follow up with the appropriate parties and respond accordingly with the answer or your next steps for a solution.  If you would prefer to speak with a person, just send the HD a quick email that says, “Please call me @ 1-1234”

19. AURA Help Desk 19 Please also continue to reach out to your normal channels of support  IRB Staff and Directors  Any other supporting office

20. Log into AURA-IRB Training Environment 20

21. Log in 21 AURA-IRB Environment https://auratraining.uchicago.edu/IRBTrain1 Research Team Member: _mditka Password : AURA2014!

22. NOW YOU TRY! 22 Diana needs to login in to AURA- IRB and create a New Study. Where does she start? What does she do?

23. NOW YOU TRY! 23 The IRB has sent requested changes to Lucia study and sent it back for updates. On her personal workspace, what tab does she select to access this study that requires her immediate attention?

24. NOW YOU TRY! 24 Rhonda receives a call from the IRB asking her to upload her grant application associate with her study. What activity does she select to accomplish this task?

25. NOW YOU TRY! 25 Charles’ study is the in the “Forward to PI for endorsement state”. The PI calls and request changes to the study. Locate the study and correct activity button to make edits.

26. NOW YOU TRY! 26 The IRB has approved your study! Now Crystal needs to print the approval letter. Locate the approval letter on your study workspace.

27. NOW YOU TRY! 27 Carla has to print her approved consent forms to enroll more subjects in the study. Where does she find them her study workspace?

28. NOW YOU TRY! 28 Marianne and Anne wants to grant a person “view only access to her study”. They will not receive notifications. Which activity button will she use on her study workspace?

29. 29 What did we Learn?

30. Questions? March 2014 30