1. Ver. 02/13/2013 1

2.  Registration  New Studies  Continuing Reviews  Amendments  Reportable Events  Tips & Tricks  Questions 2

3. eIRB: Electronic IRB System  ARC (Applications for Research Compliance)  Electronic system which houses eIRB, eIACUC and eCOI applications  USF IRB’s electronic system:  Study Teams: Complete and submit IRB applications and subprojects (Continuing Reviews, Amendments & Reportable Events)  USF Departments & USF Affiliates: Issue departmental level approvals  Institutional Review Board: Process and review applications, communicate with study teams, and issue final approvals  Electronic regulatory file 3

4. 4

5. Getting Started: Registration  To access and use ARC, you must register:  https://arc.research.usf.edu/prod https://arc.research.usf.edu/prod  Quick links are available on the ORI, DRIC and IRB homepages  Complete all the fields on the registration form  Your name, e-mail address, phone number, department name, etc. (please avoid using abbreviations)  Request your user Roles  Your User Name and Password will be e-mailed to you within 2 business days 5

6. ARC Homepage 6

7. Registration Form 7 Items marked with a * are required fields

8. 8 My Home

9. Inbox  Lists all applications that require action by you or other staff on your study team 9 * If an item is in your Inbox, it still requires your attention*

10. 10

11. Create a New Study  1) Complete SmartForm  Study team answers questions providing details about their research proposal  2) Team Members Agree to Participate  The PI and all study personnel answer questions related to conflict of interest before the application can be submitted  3) Submit Study  Only PI can submit Study 11

12. Create a New Study 12

13. Smart Form Navigation 13 Does Not Save Saves Application Current Page Required Pages Not Required Pages

14. Study Team Roles  PI – create studies and subprojects (Continuing Reviews, Amendments and Reportable Events), respond to requested revisions, submit/withdraw study and subprojects  Study Coordinator (s) – create studies and subprojects and respond to requested revisions, submit/withdraw subprojects  Can now have up to 2 coordinators on a study  Co-Investigator(s) – create and edit studies and subprojects  Cannot submit or withdraw  Key Personnel– view only access 14

15. Study Team: Role Selection  Trouble finding someone?  Usually indicates they are not registered  They may not have the appropriate role 15

16. Study Team: Education & CVs 16  The PI’s CV and education shows at the top.  Certification not current will need to be updated.  CVs can be uploaded through an activity or Agree to Participate.

17.  Human Subject Protection Education  Any individual directly involved in the conduct of clinical or social and behavioral research must have current training  Not Current education will hold up approval but not submission  Completed through CITI Program  https://www.citiprogram.org https://www.citiprogram.org  Courses are valid for two years  Valid courses detailed on ARC Homepage 17 Study Team: Education

18. SmartForm Application 18 SmartForms branch to the appropriate pages based on your selections

19. Documents in eIRB 19

20. eIRB Application – Final Page 20 Clicking Finish or Exit will bring you to the Study’s Workspace ***Clicking Finish does NOT submit your study!!!***

21. Study Workspace 21

22. Study Workspace 22  The top section shows the Current State of the study and the various ways you can view the application.  My Activities: Use these to move the application through the review and approval process.  The activities available will vary according to the role you have on the study and the “State” of the study.  Upload Team Member CV: Upload CV to profile, only have to upload once.  Upload Team Member Education Certification: Upload education certificates, dates will be updated by IRB office.

23. 23  The study’s title and Pro- number can be found to the right of the workspace.  The History tab will show all activities completed on the study.  The Attachments tab will show all sections where attachments can be made. Study Workspace

24. 24 The workspace is displayed when you: Select Exit or Finish in the SmartForm Select your application from your homepage Select the application link from an email notification

25. Agree to Participate 25

26. Submit the Study 26  Two ways to ensure the application was submitted:  The state of the study has changed from Pre Submission  Under the History tab, you will see a new activity listed that shows PI Submitted Study

27. The Path to IRB Approval  After the PI has submitted the application, it is routed to the next states  The study team will receive email notifications when the application requires their attention  Please Note : The study is not officially approved until you have received the IRB Approval Letter! 27 At any point in this process, you can log in to ARC to see where your eIRB application is on the path to approval! Pre Submission Affiliate/ Department Review IRB ReviewApproval

28.  Reviewers may request revisions or additional information at each stage of this process  The application will return to the study team’s Inbox  Study teams should respond to these concerns via eIRB.  Responding to concerns is a 3 step-process:  Correct  Respond  Submit 28 Requested Revisions

29.  Click the Reviewer Notes tab to see all the notes that were added  Click the Jump To link to take you to the page of the application where the requested change needs to be made 29 Requested Revisions

30. 30 STEP ONE: RRead the Requested Change placed on the page of the question. CComplete the request on the application. IIf a revised document needs to be uploaded, use the Upload Revision button. STEP TWO:  Respond to the Reviewer Note.  Your response will turn green  Some changes may add new pages with questions that need to be answered.  Click Continue through the rest of the application STEP THREE:  Once all changes have been made, Save and Exit the application.  You will return back to the Study Workspace.  Under My Activities, click on Submit Requested Revisions or Information  This moves the application back to the person who requested revisions.

31. Changes Submitted 31  The state has returned to Department, Affiliate or IRB Staff Review  Under History, you can see the amount of logged changes, by whom and the date and time the revisions were submitted.

32. To find your approved study:  From your Personal Folder or from IRB Studies at the top of the page, click on the Approved Studies tab.  Find the appropriate study and click on the title to reach the study’s main workspace. Approved Study Workspace 32 Approved Study’s Workspace:  You can find the approval letter and approved documents.  You can locate additional applications to be filled out.

33. Study Subprojects  All subprojects use SmartForms and require IRB Review and approval  Continuing Reviews request an extension of your study’s approval period  Amendments allow you to make changes to the approved study  Reportable Events are used to notify the IRB of incidents that require IRB review 33

34. Only One at a Time  You can only have one Amendment or Continuing Review opened at a time.  Reportable Event applications are the only exception. 34

35. 35

36. Notes about Submitting Continuing Reviews  No changes to the study can be made at the time of continuing review.  An amendment will need to be submitted and approved prior to or after the Continuing Review has been opened and completed (approved, disapproved or withdrawn)  Ensure that the human subject protection education requirements are up to date for all study team members.  You can use the Upload Team Member Education Certification activity at any time to upload certificates.  Reminder notices are sent out automatically from the system 60, 45, and 30 days from expiration. 36

37. Submitting the Continuing Review 37  You will continue to receive reminder notices from the system until the Continuing Review has been submitted.

38. 38

39. Notes about Submitting Amendments  You can use one Amendment to make all necessary changes.  If you are adding Key Personnel, they will need to Agree to Participate before you can submit.  If you choose Other Changes, in addition to completing the Amendment form, you will need to make the necessary changes in the main application.  Amendments are routed directly to the IRB for processing.  If a new PI from a different department is being added, then it will go through the department or affiliate review first. 39

40. Other Changes  The first page of the Amendment will ask the types of changes you are making and for brief description. 40  Instructions and a quick guide to sections that are commonly changed are listed.  To reach the approved application, click on the link provided.

41. Submitting the Amendment 41

42. 42

43. Notes about Submitting Reportable Events  Reportable Events can be created, even if an Amendment or Continuing Review is opened and pending approval  Submission Types:  Unanticipated Problem  Data Safety Monitoring Report  Protocol Violation/Deviation  Breach of Confidentiality  Noncompliance  Other 43

44. Submitting a Reportable Event  The Reportable Event application is still available even though a Continuing Review is opened. 44  Proceed through the application.

45. 45

46. Forgot Login Credentials? 46

47. What’s My Status? Option 1: From My Home/Workspace  Login to ARC  Use the navigational tabs to filter  Click on the name of your study 47 OOn the study’s main workspace, look in the History tab. UUse the tabs to find subprojects (e.g. Continuing Reviews, Amendments, Reportable Events)

48. What’s My Status? Option 2: From IRB Studies tab  Login to ARC  Click IRB Studies at the top of the screen  Initial studies are automatically shown in: In Progress, Approved, and Archived (Completed or Withdrawn studies) tabs. 48  You can also click under Other Submission Types to show a list of those applications.  You can check the state in the In Progress tab or click on the Name link to reach the application’s workspace.

49. Important Tips  All applications must be:  1) Completed (SmartForm)  2) Submitted (Activity)  If an application is in your Inbox, it still requires your attention  Remember to Save:  Save or Continue saves your changes  Back and Exit do not save 49

50.  Access to ARC  Official regulatory site: https://arc.research.usf.edu/Prod https://arc.research.usf.edu/Prod  Need Help? Contact the ARC HelpDesk at 813-974-2880 between 8 AM and 5 PM Monday through Friday  Access to training  Demo Site for training and practice: https://arcdev.research.usf.edu/Sandbox Login: pi Password: 1234 https://arcdev.research.usf.edu/Sandbox  Need to schedule a training? Contact the IRB Office at (813) 974-5638 50

51. 51