usf research integrity & compliance eirb comprehensive training 10/07/2014

USF Research Integrity & Compliance

eIRB Comprehensive Training

10/07/2014

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

ARC Registration

• To access and use ARC, you must register at https://arc.research.usf.edu/prod

• Complete all the fields on the registration form

• Your Username and Password will be e-mailed to you

• USF Personnel can login using their NetID

ARC Homepage

Personal Homepage

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

Starting a New ApplicationAll Applications in ARC follow the same basic workflow:

1) Create the New Application

2) Complete the Smartform

3) Use Activities to Submit for Review

1. Create the New Application• Starting a new application brings you to the SmartForm

2. Complete the SmartForm

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 *

• Study Team roles provide different access

2. Complete the SmartForm

Saves ApplicationDoes Not Save

2. Complete the SmartForm

Current Page

Required Pages

Not Required Pages

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

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Training Requirements• 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 the ARC Homepage– Basic or Refresher courses will satisfy the Education requirement.

• Note: The Responsible Conduct of Research course available on CITI is not valid for IRB certification.

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

3. Submit the Application

• An incomplete SmartForm cannot be submitted

• An unsubmitted application will not be reviewed

• The Application’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)

3. Application Workspace• The Application Workspace is the homepage for your project

• The Workspace provides access to:– The SmartForm and status information– Documents including Approval Letters and Stamped Consent Forms– Activities to move the application forward in the review process

• Access the Application’s Workspace by selecting:1. Exit or Finish in the SmartForm2. The name of the application from your homepage3. The link in an ARC email notification

3. Application Workspace

Left: Action – access the Smartform and move your study through the workflow

Right: Information about your study

3. Submit the Application

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 email to complete the required activity• Once all team members agree, the PI will receive an email notification

3. Submit the Application• When an application is submitted the Workspace will update

1. The Status will change to the next review state2. The submit activity will be logged in the History tab

Application Workflow

Pre Submission Pre Review IRB Review Approval

Revisions Requested

Revisions Requested

• All Applications follow the same basic workflow• The Study Team will receive email notifications if action is

required• Applications under review will not appear in the study

team’s Inbox and cannot be edited

Requested Revisions

• Reviewers may request revisions or additional information

• The study team will receive an email and the application will be back in their Inbox

• Study teams respond to revisions by:1. Correcting the SmartForm2. Responding to the Reviewer Note3. Submitting back for review

Requested Revisions

1. Correct

2. Respond

Requested Revisions

3. Submit (PI or Study Coordinator)

Post ApprovalTo find your approved study:• Use the link in the email notification OR• Select the Approved Studies tab from your homepage

Post Approval

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Study Subprojects

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

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

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

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Subproject Restrictions1. You can only have one Amendment or Continuing Review

opened at a time.

2. Reportable Event applications can be created and submitted at any time.

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Finding Subprojects Subprojects are accessible from:

– Inbox – for subprojects that require your attention– A tab on the associated main study– Corresponding item on the IRB Studies menu

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Continuing Reviews Reminder notices are sent out automatically at 60, 45, and 30

days from study expiration.

No changes to the study can be made at the time of continuing review.– Amendments need to be submitted and approved prior to, or

after, the Continuing Review has been submitted & approved.

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.

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Amendments

• 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 is being added or an affiliate site is

added, then it will go through the department or affiliate review first.

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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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TIPS & TRICKS

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Forgot Login Credentials?

Forgot Login Credentials?

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Easy NavigatingSelect the application link from an email notification.

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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.

• Actions Look to the left side menu• Remember to Save:– Save or Continue saves your changes– Back and Exit do not save

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Contact Information• Access to ARC

– Official regulatory site: https://arc.research.usf.edu/Prod– Need Help? Contact the ARC HelpDesk:– 813-974-2880 between 8 AM - 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