ver. 02/13/2013 1. registration new studies continuing reviews amendments reportable events ...
TRANSCRIPT
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1Ver. 02/13/2013
eIRB Comprehensive
Workshop
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Agenda Registration New Studies Continuing Reviews Amendments Reportable Events Tips & Tricks Questions
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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
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Registration
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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
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ARC Homepage
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Registration Form
Items marked with a
*are required fields
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My Home
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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*
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New Studies
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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
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Create a New Study
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Smart Form Navigation
Does Not Save
Saves ApplicationCurrent Page
Required Pages
Not Required Pages
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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
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Study Team: Role Selection
Trouble finding someone? Usually
indicates they are not registered
They may not have the appropriate role
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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.
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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
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SmartForm ApplicationSmartForms branch to the appropriate pages
based on your selections
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Documents in eIRB
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eIRB Application – Final Page
Clicking Finish or Exit will bring you to the Study’s Workspace***Clicking Finish does NOT submit your study!!!***
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Study Workspace
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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.
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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
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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
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Agree to ParticipateThis will send an email to all Study Team members. This activity can be
repeated if necessary.
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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
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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 Submission
Affiliate/ Departmen
t ReviewIRB Review Approval
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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
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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
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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.
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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.
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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.
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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
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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.
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Continuing Reviews
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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.
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Submitting the Continuing Review
You will continue to receive reminder notices from the system until the Continuing Review has been submitted.
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Amendments
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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.
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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.
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Submitting the Amendment
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Reportable Events
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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
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Submitting a Reportable Event
The Reportable Event application is still available even though a Continuing Review is opened.
Proceed through the application.
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Tips & Tricks
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Forgot Login Credentials?
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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)
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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.
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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
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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
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Questions?