1Ver. 02/13/2013

eIRB Comprehensive

Workshop

2

Agenda Registration New Studies Continuing Reviews Amendments Reportable Events Tips & Tricks Questions

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

4

Registration

5

Getting Started: Registration

To access and use ARC, you must register: 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

6

ARC Homepage

7

Registration Form

Items marked with a

*are required fields

8

My Home

9

Inbox Lists all applications that require action

by you or other staff on your study team

* If an item is in your Inbox, it still requires your attention*

10

New Studies

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

12

Create a New Study

13

Smart Form Navigation

Does Not Save

Saves ApplicationCurrent 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

15

Study Team: Role Selection

Trouble finding someone? Usually indicates

they are not registered

They may not have the appropriate role

16

Study Team: Education & CVs 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 Courses are valid for two years Valid courses detailed on ARC Homepage

Study Team: Education

18

SmartForm ApplicationSmartForms branch to the appropriate pages

based on your selections

19

Documents in eIRB

20

eIRB Application – Final Page

Clicking Finish or Exit will bring you to the Study’s Workspace***Clicking Finish does NOT submit your study!!!***

21

Study Workspace

22

Study Workspace 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

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

Study WorkspaceThe 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 ParticipateThis will send an email to all Study Team members. This activity can be

repeated if necessary.

26

Submit the Study 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!

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 Submissio

n

Affiliate/ Departmen

t ReviewIRB Review Approval

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

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

Requested Revisions

30

Requested RevisionsSTEP ONE:

Read the Requested Change placed on the page of the question.

Complete the request on the application. 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 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

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

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.

35

Continuing Reviews

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.

37

Submitting the Continuing Review

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

38

Amendments

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.

40

Other Changes

The first page of the Amendment will ask the types of changes you are making and for brief description.

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

42

Reportable Events

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

44

Submitting a Reportable Event

The Reportable Event application is still available even though a Continuing Review is opened.

Proceed through the application.

45

Tips & Tricks

46

Forgot Login Credentials?

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

On the study’s main workspace, look in the History tab.

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.

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

50

Important Information Access to ARC

Official regulatory site:https://arc.research.usf.edu/Prod

Need Help?Contact the ARC HelpDesk at 813-974-2880between 8 AM and 5 PM Monday through Friday

Access to training Demo Site for training and practice:

https://arcdev.research.usf.edu/SandboxLogin: pi Password: 1234

Need to schedule a training?Contact the IRB Office at (813) 974-5638

51

Questions?