eiRB
§ Registration § New Studies § Continuing Reviews § Amendments § Reportable Events § Tips & Tricks § Questions
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ARC: Electronic IRB System § ARC (Applications for Research Compliance)
ú Electronic system which houses eIRB, eIACUC and eCOI applications
§ USF IRB’s electronic system:
ú Study Teams: Complete and submit IRB applications and subprojects
(Continuing Reviews, Amendments & Reportable Events)
ú USF Departments & USF Affiliates: Issue departmental level approvals ú 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: ú https://arc.research.usf.edu/prod ú Quick links are available on the ORI, RIC and IRB homepages
§ Complete all the fields on the registration form ú Your name, e-‐mail address, phone number, department name, etc. (please avoid using abbreviations) ú Request your user Roles
§ Your User Name and Password will be e-‐mailed to you.
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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* 9
New Studies
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Create a New Study § 1) Complete SmartForm ú Study team answers questions providing details about their
research proposal
§ 2) Team Members Agree to Participate ú The PI and all study personnel answer questions related to conflict of interest before the application can be submitted
§ 3) Submit Study
ú Only PI can submit Study
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Create a New Study
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Smart Form Navigation Does Not Save
Saves Application
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Smart Form Navigation in-‐form “Jump To” navigation
Current Page
Required Pages
Not Required Pages
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Study Team Roles § PI – create and edit applications, respond to requested
revisions, submit/withdraw applications
§ Study Coordinator (s) – create and edit applications, respond to
requested revisions, submit/withdraw applications
ú Cannot submit the study until the PI has submitted it initially ú Can now have up to 2 coordinators on a study
§ Co-‐Investigator(s) – create and edit applications, respond to
requested revisions
ú Cannot submit or withdraw
§ Key Personnel– view only access
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Study Team: Role Selection § Trouble finding
someone?
ú Usually indicates
they are not registered ú 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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Study Team: Education § Human Subject Protection Education ú Any individual directly involved in the conduct of
clinical or social and behavioral research must have current training ú Not Current education will hold up approval but not submission
§ Completed through CITI Program
ú https://www.citiprogram.org ú Courses are valid for two years ú Valid courses detailed on ARC Homepage
ú Either Basic or Refresher courses will satisfy the
IRB Education requirement.
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SmartForm Application SmartForms branch to the appropriate pages based on your selections
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Documents in eIRB
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eIRB Application – Final Smartform Page
Clicking Finish or Exit will bring you to the Study’s Workspace
*** Clicking Finish does NOT submit your study!!!*** 21
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. 23
Study Workspace § 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.
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Study Workspace The study workspace is displayed when you: 1. Select Exit or Finish in the SmartForm , or…
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Study Workspace ...when you: 2. Select your application from your homepage, or
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Study Workspace …when you: 3. Select the application link from an email notification
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Agree to Participate
This will send an email to all Study Team members. This activity can be repeated if necessary.
Include custom message to study team members here.
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Agreement to Participate: • As a member of the study team,Iunderstand that I have responsibilities related to the conduct and oversight of this research study. II with all documents that comprise this submission. Iwill ensure this research study is conducted in accordance with the ethical principh institutional policies,and federal and state regulations. 0Yes 0No Clear
Pre Submission
Ll:] Edit Study
J ( Printer Version rl.,-,'"'· V-ie_w_ S_m_art_F_orm Pro_g_r_ess- -.,J
Conflict of Interest Disclosure 1.) Do you or an immediate family member hold equity interest in, receive personal compensation from,or have a business relationst as officer,director,partner,trustee,board member, scientific advisory board member,etc) with an entity (e.g.,the sponsor, provic being investigated or equipment/services being offered, or the holder of any ownership interest in a product being investig "";earch outlined in this proposal? 0Yes 0No Clear 2.) Do you or an immediate family member have a proprietary interest (including trademark, patent,copyright, licensing agreement o orcmertv lassociated with the research outlined in this proposal (e.g., the drug or device)? 0Yes 0No Clear
If you have answered yes to either of the questions outlined above, please upload evidence of your institutions acknowledgement, r is conflict of interest (i.e., the conflict of interest management plan).
you have answered yes to quesltons 1 and 2 above, and have not submitted your CO/ disclosure,please go to hltps.llarc .research .usf.edu/Prod It and obtain a management plan.
J
rn
Agree to Participate and
r;tl Withdraw Study (SSl Edit Email List
to employ a related person in a paid capacity on this research project, you must complete the COl dtsclosure form at h ps f/8/c.r• search.ust edu/Prod to teporl nepotism in research. note that finai/RB approval will not be gtanled until /he IRB receives a conflict olinterest management plan or other document from your ins institutioo• awareness and management olthe conflict. In addition, if during the course olthe study should you acqwe a finanCial mteresl or enter 1 relationship (as ou/Jmed abow1) wh1ch has not been previously disclosed to the /RB, it is your responsibility to notify the IRB v1a an amendment.
Edit Guest List
fSsl Upload Tearn Member CV
f Biosketch
Please attach your current CV/Biosketch here. If it is already current,there is no need to replace it: CV HERE(O 02) I Uplood Revision II Oelete I
[Ssl Upload Team Member Education Certificat ion
To Submit the Study
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Submit the Study
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Study Submitted § Two ways to ensure the application was submitted:
1. The state of the study has changed from Pre Submission
2. 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 Pre Submission
Affiliate/ Department Review
IRB Review
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!
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Requested Revisions § 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 respond to these concerns via ARC. · Responding to concerns is a 3 step-‐process:
1. Correct 2. Respond 3. Submit 34
Requested Revisions
§ Click the Reviewer Notes tab in the study workspace 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
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Requested Revisions STEP ONE: § Read the Requested
Change placed on the page of the question.
§ Complete the request
on the application.
ú If a revised document
needs to be uploaded, use the Upload Revision button. 36
Requested Revisions
STEP TWO:
§ Respond to the
Reviewer Note! ú Your response will
turn green
§ Some changes may
add new pages with questions that need to be answered. ú Click Continue
through the rest of the application
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Requested Revisions STEP THREE:
§ Once all changes have been made, Save and Exit the
application.
ú You will return back to the Study Workspace.
§ Under My Activities, click on:
Submit Requested Revisions or Information,
§ Then click ‘Ok’ in the resulting dialog box.
This moves the application back to the person who requested the revisions 38
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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Approved Study Workspace
To find your approved study:
§ From My Home 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.
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Approved Study Workspace
In the Study’s Workspace you will find: 1. the approval letter, 2. the attachments tab with approved
documents, 3. additional applications to be filled out (amendments, Reportable Events and Continuing/Final Reviews).
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Study Subprojects
All subprojects use SmartForms and require IRB Review and Approval
ú Continuing Reviews · request an extension of your study’s approval period ú Amendments · allow you to make changes to the approved study ú Reportable Events · are used to notify the IRB of incidents that require IRB review 42
Only One at a Time § You can only have one Amendment or Continuing Review
opened at a time.
§ Reportable Event applications can be created and submitted
at any time.
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Continuing Reviews
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Notes about Submitting Continuing R eviews No changes to the study can be made at the time of
continuing review.
ú 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.
ú 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. ú If you are adding Key Personnel, they will need to Agree to Participate before
you can submit. ú 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.
ú 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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Select Changes
§ The first page of the Amendment will ask the
types of changes you are making and for brief description.
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“Other Changes” selection § Instructions and a
quick guide to the sections (in the approved study) that are commonly changed are listed.
§ To reach the
approved application to make changes, click on the link provided.
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Submitting the Amendment
After you click Finish, you will exit the form and will be directed to the Amendment Workspace. If you added study team members, use the Notify Team Member to Agree to Participate activity. 51 After all agreements are received, use the Submit Amendment activity.
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: ú Unanticipated Problem ú Data Safety Monitoring Report ú Protocol Violation/Deviation ú Breach of Confidentiality ú Noncompliance ú Other
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Opening a Reportable Event
The Approved Study Workspace
The Reportable Event application is still available even though a Continuing Review is opened.
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Reportable Events Smartform
Proceed through the application smartform just like in the other projects. The form will branch as necessary. 55
Submitting a Reportable Event
When finished with the form, remember to use the submit activity to send it to the IRB for review.
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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
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What’s My Status? Option 1: From My Home Workspace § Once on the study’s main workspace, the current state will display in the
red box on the left.
§ Use the tabs to find subprojects (Continuing Reviews, Amendments,
Reportable Events)
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What’s My Status? Option 2: From IRB Studies tab § 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. § The status is viewable in the State column § The Name column will have a link to the subproject workspace for
more details.
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What’s My Status?
Option 2: From IRB Studies tab
§ 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: ú 1) Completed (SmartForm)
ú 2) Submitted (Activity)
ü ü
§ If an application is in your Inbox, it still requires your attention. § Remember to Save:
ú Save or Continue saves your changes ú Back and Exit do not save
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§ Access to ARC
ú Official regulatory site: https://arc.research.usf.edu/Prod
ú Need Help? Contact the ARC HelpDesk: ú 813-‐974-‐2880 between 8 AM -‐ 5 PM Monday through Friday
§ Access to training
ú Demo Site for training and practice:
https://arcdev.research.usf.edu/Sandbox Login: pi Password: 1234
ú Need to schedule a training?
Contact the IRB Office at (813) 974-‐5638 64
ARC Helpdesk: Email: RSCH-‐
[email protected]:
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