Advarra IRB

Advarra is a commercial IRB and is not affiliated with Emory University.

Emory has agreed to rely on the Advarra IRB for some multi-site industry sponsored clinical trials and for federally funded research when use of a single IRB is required and Advarra has been chosen as the single IRB.

When using Advarra as the single IRB, the Emory study team must first submit an external IRB (XIRB) submission to the Emory IRB to ensure local requirements are met and will then submit to Advarra through the online CIRBI system.

Even though the Advarra IRB is considered the single IRB of record for the study, Emory study teams are responsible for reporting certain information to the Emory IRB for the life of the study. Click on the tabs below to learn more about these reporting requirements.

 Please click on the frequently-asked questions below for information about Advarra.


 

General Information

Advarra IRB

For studies reviewed by Advarra, the protocol-level review for the lead site/sponsor should already be completed, and Emory is simply added as an additional study site via amendment. Learn more at www.advarra.com.

What is Emory IRB's role in Advarra-reviewed studies?

As in other external IRB (XIRB) studies, Emory IRB will verify that all local institutional requirements are met via a local eIRB submission, including

  • study team training requirements
  • ancillary committee reviews

 

Submission Process

Step 1 – Determine Emory IRB’s willingness to rely on Advarra

  • Fill out Form A (now electronic form) and save a copy of the submitted form.  If the Form says that the study is not eligible for Advarra review, submit to the Emory IRB as usual.  If the form agrees that you can use Advarra, you will create an "external IRB" submission in eIRB.

Step 2 – Obtain Advarra CIRBI accounts for the study team

  • Required for those needing to submit to Advarra or receive notifications
  • Advarra recommends scheduling a CIRBI demo so that they can walk you through the use of the CIRBI platform.

Step 3 – Submit an Emory Local Submission (XIRB) in eIRB

  • Use this guidance document to complete the abbreviated XIRB submission in eIRB.
  • Upload the Advarra-approved master consent form and study-wide approval letter.
  • Use the External IRB Consent Checklist to determine the Emory language to insert into the master consent form using TRACKED CHANGES. Upload the Emory consent form in the local site documents section of the smart form. 
  • The reliance team will review the consent form and confirm all local requirements are met such as departmental reviews, confirmation of Cost and In Case of Injury language options from OCR and OSP, ancillary reviews (such as radiation safety, biosafety, or LITS) and investigator training.
  • Once all local requirements are met, the Emory IRB will log a comment with institutional signoff. You cannot submit to the Advarra IRB before the Emory IRB has issued this signoff. 

Step 4 - Submit to the Advarra IRB

  • Since the sponsor/lead site will have already used Advarra for protocol review, you will be submitting an amendment.  Contact Bette Bayne or Betsy Casillo to be given access to the study in order to submit the amendment (if the sponsor/lead site has not already provided you access to the study).
  • List "Emory" as the site where the research is taking place on the site/investigator application.
  • Use our guidance form to complete the Site and Local Context information section.
  • Advarra only requires that you list the site PI as a contact on the site/investigator application, but you can add whomever you wish as long as the individual has a CIRBI account.
  • When submitting to Advarra, include a clean version of the Emory consent form that was submitted to the Emory IRB for review, the completed consent form checklist, and a screenshot of the institutional signoff.  (Note: The Advarra coordinator will not send your study for review until they receive the Emory IRB signoff).
  • Once you submit, your submission will be assigned an Advarra coordinator.  The coordinator will review your submission and request clarification if needed. 
  • You may log into CIRBI at any point to check the status of your submission via the "status bar."

What if CHOA is involved?

If an Emory PI is conducting research either 1) at a CHOA site and an Emory site or 2) at a CHOA site only, only ONE application to Advarra is needed.  You may list both CHOA and Emory as "research locations" under the one submission.

If there will be two PIs for a study, one for a CHOA/child site and one for an Emory/adult site, you should do two separate submissions for the two different PIs.  You should still list Emory as a "research location" on the CHOA/child site if the CHOA/child site's PI is an Emory faculty member.

What happens post-approval?

After your study is approved, Advarra will be the IRB of record for the life of the study.  All communication regarding the study will be between the investigator and Advarra. 

Documents for submitting amendments and continuing reviews to Advarra can be located on CIRBI via the study's hyperlink.

See the Modifications tab below for more informaiton regarding requirements to update the Emory IRB.

What forms do I need for my submission?

External IRB Consent Checklist

XIRB Smartform Guidance Document

IRB Handbook (Reference Materials section of the Advarra CIRBI Platform)

Advarra promptly reportable information form (Reference Materials Section of the Advarra CIRBI Platform)

Modifications (Changes to ongoing research)

All modifications need to be submitted to the Advarra IRB. However, note that most reviewing IRBs do not review local study team changes.

You must promptly inform the Emory IRB of the following changes to research:

  • changes to drugs or devices used in the study
  • change to Emory PI and study personnel who need immediate access to eIRB
  • changes to Emory-affiliated study sites
  • changes in financial interests on the part of Emory investigators
  • new funding mechanisms
  • changes to the Clinical Research Key Points (CRKP) Summary

No other changes need to be submitted locally to us at this time (subject to change).

Ancillary Review Changes: It is the responsibility of the Emory Principal Investigator to notify ancillary review committees if changes are made to approved research that may impact the reviews of these committees. Examples include, but are not limited to, changes relevant to radiation, conflict of interest, and biosafety review. 

How to Submit to Emory IRB in eIRB

Depending on the state of your approved study, do the following:

Continuing Reviews

The Advarra IRB is responsible for conducting the continuing review. When prompted by Adviarra or the lead study team, submit your renewal documents to Advarra.

Once your site has received continuing review approval from the Advarra IRB, next steps depend on whether you are the PI or a Co-I/Coordinator...

If you are the PI, select "Report Continuing Review Data" on the left menu in the study workspace in eIRB to update the Emory IRB, and submit the documents listed below.

If you are not the PI, submit the below items via "Log Comment" and select that you want to notify the IRB Coordinator. The IRB Coordinator will then process the continuing review on your behalf. 

Please submit the following to the Emory IRB:

  • The renewal approval letter from the Advarra IRB.
  • Updates to local study team members (that have not already been reported)
    • This must be done via a simultaneous study update (see Modifications section above)
  • A summary of all internal Reportable New Information (RNIs) submitted to the reviewing IRB since the last review, if any (and if not already reported promptly).
    • RNIs include but are not limited to unanticipated problems that increase risk of harm to others, noncompliance, breaches of confidentiality, wrong site surgeries, wrong drug administered, wrong patient, fabrication of data and falsification of data. 
    • In the summary, provide the outcome of the reviewing IRB's review (e.g. "Noncompliance," "Serious noncompliance," "Unanticipated Problem"...) 
    • Note: The reviewing IRB may call these submissions something different, e.g. "Reportable Events" 
    • Upload a copy of the report(s) submitted to the reviewing IRB. 
    • attach the completed CR workbook.

Reportable Events

You must report reportable events/new information to the Advarra IRB according to the Advarra IRB's policies and procedures.

Most reports should be made to the Advarra  IRB only. However, some reports must also be submitted to the Emory IRB (see below).  If in doubt, report to Emory anything that Emory IRB would require to be reported, and if the Advarra's IRB’s rules go beyond our requirements, you must follow their policies as well. 

Emory IRB:

Report egregious reportable events promptly to Emory office of Compliance, Risk Management Office, and Emory IRB IN ADDITION to the Advarra IRB.

Examples of egregious reportable events:

  • the wrong side surgery
  • the wrong drug, wrong patient
  • fabrication or falsification of data
  • HIPAA privacy matter (report any inadvertent data disclosure and we will help determine further actions)

How to report to Emory IRB: Click on "Report New Information" on the left menu of the study workspace in eIRB.

  • Egregious events (reported promptly): Upload a copy of the report(s) made to the reviewing IRB, and any correspondence from the reviewing IRB (but do not delay to wait for their determination).
  • Events reported to the External IRB in the past approval period: Submit to the Emory IRB at the time of continuing review.  Click Report Continuing Review Data on the left menu.  Under question 4, attach the filled CR workbook.

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See our submissions guidance table here.

Contacts

Emory Contacts

Advarra Contacts