Note to File Re: Statement of Investigator, Form FDA 1572 2019

Dear Customer,

As previously announced, Advarra, Inc. (“Advarra”) acquired Quorum Review, Inc. (“Quorum”) effective February 28, 2019.

On May 1, 2019, all new studies submitted will be managed under Advarra’s FDA/OHRP registration (IRB00000971). Advarra (IORG000635) will begin transferring all ongoing studies previously under Quorum IRB oversight to Advarra IRB, and all studies will fall under the Advarra FDA/OHRP registration once the transfer is complete. Quorum’s FDA/OHRP registration (IRB00003226) will remain active in the interim under the Advarra name. Once all Quorum studies are transferred, the Quorum registration number will be deactivated.

The FDA does not require that an updated or new 1572 be completed to reflect this change in information; however, FDA recommends that the investigator document the change in the clinical study records and inform the sponsor of these changes.¹ This Note to File may serve as this documentation. Click here to access a downloadable PDF version of this information.

The following addresses should be used for new 1572s:

We look forward to continuing our relationship with your company.

Sincerely,

Michele Russell-Einhorn
Chief Compliance Officer and Institutional Official, Advarra

¹Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs, Frequently Asked Questions – Statement of Investigator (Form FDA 1572), May 2010, available at https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf

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