1. USF Research Integrity & Compliance
eIRB System Training
10/15/2018

2. What is ARC? ARC (Applications for Research Compliance)
Electronic system which houses eIRB, eIACUC and eCOI applications
ARC is used by:
Study Teams to create and submit research related applications
Staff to facilitate the review of study applications
Reviewers to review the applications
Users gain access by registering for an ARC account

3. ARC Registration
To access and use ARC, you must register at
Complete all the fields on the registration form
Your Username and Password will be ed to you
USF Personnel can login using their NetID

4. ARC Homepage

5. Personal Homepage

6. Inbox
Lists all applications that require action by you or other staff on the study team
Selecting the application’s Name will bring you to the workspace

7. Starting a New Study Create the New Study Complete the Smartform
Use Activities to Submit for Review
All Applications follow the same basic submission process

8. 1. Create the New Study
Starting a new application brings you to the SmartForm

9. 2. Complete the SmartForm

10. 2. What is a SmartForm?
The SmartForm is an electronic form where you answer questions about your research project
It is a SmartForm because it uses your answers to branch only to pages relevant to your research
Required questions are marked with a red asterisk *

11. 2. Complete the SmartForm
Does Not Save
Saves Application

12. 2. Complete the SmartForm
Current Page
Required Pages
Not Required Pages

13. 2. Study Team: Role Selection
Roles provide different access
You can only add researchers with active ARC accounts

14. 2. Study Team: Training Requirements
All Study Team Members must have current education prior to study approval
Education Status is displayed on page 1.2 of the SmartForm

15. 2. Study Team: Training Requirements
Fulfilled by completing a valid course with the CITI Program
Register at
Courses completed after April 1, 2015 are valid for 3 years
Most researchers should complete either:
Biomedical Investigators and Key Personnel; or
Social/Behavioral Investigators and Key Personnel
Additional valid courses detailed on the ARC Homepage
Note: The Responsible Conduct of Research is not valid for IRB certification.

16. 2. Complete the SmartForm
Continue through the SmartForm completing all required questions
Selecting Exit or Finish in the SmartForm brings you to the Application’s Workspace
Clicking Finish does NOT submit your study

17. 3. Submit the Study An incomplete SmartForm cannot be submitted
An unsubmitted Study will not be reviewed
The Study’s Workspace provides access to the Activity necessary to submit
Only the PI can submit the Study for Initial Review
Subsequent submissions can be completed by the Study coordinator(s)

18. The Workspace is your study’s homepage
3. Study’s Workspace
The Workspace is your study’s homepage
The Workspace provides access to:
The SmartForm and status information
Documents including Approval Letters and Stamped Consent Forms
Activities to move the study forward in the review process
Access the Study’s Workspace by selecting:
Exit or Finish in the SmartForm
The name of the Study from your homepage or IRB Studies menu
The link in an ARC notification

19. 3. Study’s Workspace
Left: Action – access the Smartform and move your study through the workflow
Right: Information about your study

20. 3. Submit the Study

21. 3. IRB: Agreement to Participate
IRB Studies require study team members to Agree to Participate before the Principal Investigator can submit
Notified team members receive an to complete the required activity
Once all team members agree, the PI will receive an notification

22. 3. Submit the Study
When an application is submitted the study Workspace will update:
The Status will change to the next review state
The submit activity will be logged in the History tab

23. Study Workflow All Studies follow the same basic workflow.
Pre Submission
Pre Review
IRB Review
Approval
Revisions Requested
Revisions Requested
All Studies follow the same basic workflow.
The Study Team will receive notifications if action is required.
Studies under review will not appear in the study team’s Inbox and cannot be edited.

24. Requested Revisions
Reviewers may request revisions or additional information via Reviewer Notes.
The study team will receive an and the application will be back in their Inbox
Study teams respond to revisions by:
Correcting the SmartForm
Responding to the Reviewer Note
Submitting back for review

25. Requested Revisions
Reviewer Notes are placed on pages in the SmartForm. They can be accessed by selecting:
Edit Study to access the SmartForm
Reviewer Notes tab to view all notes

26. Requested Revisions
2. Respond
1. Correct

27. 3. Submit (PI or Study Coordinator)
Requested Revisions
3. Submit (PI or Study Coordinator)

28. Post Approval To find your approved Study:
Use the link in the notification OR
Select the Approved Studies tab from your homepage

29. Post Approval

30. Study Subprojects Continuing Reviews Personnel Change Request
request an extension of your study’s approval period or closure
Personnel Change Request
allow you to add and remove non-PI study team members
Amendments
allow you to make changes to the approved study
Reportable Events
are used to notify the IRB of incidents that require IRB review

31. Post Approval: Subprojects
Subprojects follow the same process as the initial study
Create the Application
Complete the SmartForm
Submit for Review
Each subproject has its own workspace
Subprojects that require your attention will show up in your Inbox

32. Creating Subprojects Go to the associated study’s main workspace.
Look to the bottom of the left side menu for the subprojects available.

33. Subproject Restrictions
Only one Amendment or Continuing Review can be opened at the same time.
Personnel Change Requests are available during Continuing Review, but not if an Amendment is open.
Reportable Event applications can be created and submitted at any time.

34. Continuing Reviews (CR)
Reminder notices are sent out automatically at 60, 45, and 30 days from study expiration.
Only non-PI study team changes can be made during the continuing review (using Personnel Change Request).
Tip: Ensure that the IRB 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.

35. Amendments (AME)
You can use one Amendment to make all necessary changes.
If you are adding new study team members, 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 or an affiliate site is being added, then it will route through department or affiliate review first.

36. Personnel Change Requests (PCR)
A simplified process to change non-PI personnel.
Uses a streamlined form and review process
Can be created while a Continuing Review is outstanding.
Prior to submission:
All study team member must have current IRB Certification
All new team members must agree to participate
Approval is documented in an to the study team.

37. Reportable Events (RE)
Reportable Events can be created at any time after approval
Multiple REs can be open at the same time
Submission Types:
Unanticipated Problem
Data Safety Monitoring Report
Protocol Violation/Deviation
Breach of Confidentiality
Noncompliance
Other

38. Finding Subprojects Subprojects are accessible from:
your ARC Inbox – for subprojects that require your attention or
a tab on the associated main study
Note: Personnel Change Requests (PCR) are found in the Amendments section

39. Tips & Tricks

40. Forgot Login Credentials?

41. Forgot Login Credentials?

42. Select the application link from an email notification.
Easy Navigating
Select the application link from an notification.

43. Subproject Workspace
Use the breadcrumbs to navigate back to the main study workspace.

44. Important Tips    All applications must be: Created
Completed (SmartForm)
Submitted (Activity)
If an application is in your Inbox, it still requires your attention.
Actions  Look to the left side menu
Remember to Save:
Save or Continue saves your changes
Back and Exit do not save   

45. Contact Information
Access to ARC
Official regulatory site:
Need Help? Contact the ARC Help Desk:
between 8 AM - 5 PM Monday through Friday
Access to training
Demo Site for training and practice: Login: pi Password: 1234
Need to schedule a training? Contact the IRB Office at (813)