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Advarra IRB Reliance

 What is Advarra?

Advarra Institutional Review Board (IRB) is an independent IRB formed in 2017 from the merging of two major central IRBs - Chesapeake IRB and Schulman IRB. Advarra provides services for academic and non-academic institutions. 

Chesapeake IRB has provided independent IRB submission and review services to research sponsors, CROs, investigators and academic medical centers and hospital systems since 1993.  The paperless, cloud-based submission and review platform originally developed by Chesapeake IRB, the Center for IRB Intelligence or “CIRBI,” has been further enhanced by Advarra and continues to lead the field in setting the standard in quality, easy document accessibility and review turnaround time.

Founded in 1983, Schulman IRB has long been a leader in the protection of human research participants. By offering thorough, timely IRB review services - including dedicated review capabilities for all phases of research across all therapeutic areas - Schulman IRB became a preferred provider for many of the world’s largest clinical trial sponsors, CROs, investigators and institutions. Schulman also pioneered specialized, expert therapeutic review services such as Central Oncology Review (COR) and Central Neurology Review (CNR).



What Type of Studies Qualify for Advarra Review?

Studies that meet all of the following criteria are eligible for Advarra review: 

  • Phase IIb, III or IV clinical trials
  • Industry authored
  • Industry funded
  • Sponsor/CRO has contracted with Advarra or with an affiliated IRB (i.e., Schulman IRB, Chesapeake IRB, Copernicus Group IRB, Aspire IRB, MidLands IRB and New England IRB) to provide IRB services for the study (documentation required)

Exceptions

Studies involving the following procedures or populations do not qualify for Advarra review:

  • Surgical techniques or procedures
  • Transplant techniques, procedures or other interventions
  • Stem cell therapies
  • Gene therapy or gene transfer
  • Investigational radiologic procedures
  • FDA-approved or investigational radiological agents
  • Neonates

UCI IRB reserves the right to make additional exceptions and has final say on whether UCI IRB review is required. 

 

How do I obtain clearance from UCI to submit to Advarra?

Advarra IRB will not review research on behalf of UCI without a formal ‘Clearance Notice’ issued by UCI IRB.  

A.   Pre-Submission

The UCI Lead Researcher (LR):

  • Determines that study meets eligibility criteria for Advarra review. If there are any questions, contact the UCI IRB staff via email at IRBReliance@uci.edu for guidance.
  • Confirms that Sponsor/CRO has contracted with Advarra or its affiliates to provide IRB services for this study and that sponsor will cover cost of Advarra review.  Documentation required.
  • Includes the UCI IRB fees (expedited IRB fee rate) in the clinical trial budget for administrative review and oversight.
  • Initiates process, if not already started or completed, to obtain other UCI regulatory committee/ institutional approvals (i.e., Radiation Safety Committee (RSC), Conflict of Interest Oversight Committee (COIOC)), as needed.

B.  Submission to UCI

The UCI LR must submit the following documents, as applicable:

  • Sponsor Study Documents: 
    • Master Protocol
    • Investigator Brochure(s)
    • Sponsor Consent Template

 

C.  Review Process

1.  UCI IRB confirms that study is eligible for reliance on Advarra, the paperwork is complete, and all other required UCI regulatory committee approvals are obtained.

  • If study is eligible, paperwork complete and all required approvals in place, UCI IRB will send an email (ie, ‘Clearance Notice’) to the UCI LR indicating that the study is eligible for Advarra review. 
  • If study is not eligible and/or the paperwork is incomplete, or other regulatory committee approvals are not provided, UCI IRB will notify UCI LR in writing of the determination or additional requirements.

2.  Once eligibility is confirmed, a formal ‘Clearance Notice’ is sent to the UCI LR that the study may be submitted for Advarra review through CIRBI.

3.  Advarra reviews LR's documentation and communicates directly with UCI LR with respect to any required revisions or additional information needed.

4.  Advarra sends the UCI IRB notification that study has been approved. 

  • Advarra provides an approval notice, a stamped version of the approved recruitment and consent documents, which includes the UCI IRB previously-approved and agreed upon consent template language.
  • UCI IRB Staff releases the approval notice and other relevant study documents through the IRB Doc Depot.

D.  Post Advarra Approval

The UCI LR submits all other transactions to Advarra:

  • Amendments, Continuing Approval, Unanticipated Problems are reported directly to Advarra.
  • UCI IRB is notified of all Advarra approved transactions by Advarra.
  • Exceptions
  • All changes in study team personnel must be submitted to UCI through a modification request.
  • Request to access Personal Health Information (PHI) covered under HIPAA, as UCI serves as its own Privacy Board.

 

Advarra Submission and Review Process

  • If PI/Sub-I is working with Advarra for the first time, please submit a CV signed and dated within the last two years.
  • During the IRB review process, you may receive emails from different Advarra staff members who are working on your submission.
  • Once your submission has been approved by the IRB, you will receive an email notification informing you of the approval. The email will include a direct link to access the approval documents. You can also access your approval documents by signing in to Advarra’s CIRBI.  

Considering Advarra?

General Questions:

Betsy Casillo
Study Manager
betsy.casillo@advarra.com 
513-619-1679

Study-specific Questions:

Jayla Robtoy
Client Services Coordinator
jayla.robtoy@advarra.com 
410-884-2900

or cirbi@advarra.com

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