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Updated IRB Handbook Available

Advarra has updated its IRB Handbook for Investigators, Institutions, Sponsors, and Sponsors’ Representatives. Along with other changes, this version includes an update to the IRB policy on pregnancy follow up, specifically the collection of outcome/safety data on pregnant partners of male subjects and newborns born to a subject’s partner.

In accordance with this policy change, the IRB will no longer require the submission of additional documents (e.g., a separate informed consent form [ICF] for pregnant partners, authorization form, information sheet, medical release form) to collect outcome/safety data of pregnant partners.

The revised Handbook is available in the Reference Materials section of the Advarra Center for IRB Intelligence (CIRBI) Platform (login required). Clients are encouraged to check the Advarra CIRBI Platform for the latest version of the Handbook and applicable summary of changes.

The purpose of the Handbook is to orient investigators, research staff, sponsors, CROs, and SMOs to the IRB’s policies, procedures, guidelines, and expectations, including information related to the initial review process through management of ongoing research activities and study closure.

Because the Handbook includes links to external, web-based resources, Advarra recommends keeping an electronic version so that these hyperlinks remain accessible.

If you have questions about the updated Handbook, please contact your client services coordinator listed on each of your submissions.

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